Associate Director, Corporate Quality Relationships

Associate Director, Corporate Quality Relationships

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support.
Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Job Description

JOB TITLE:                     Associate Director, Corporate Quality Relationships

SELECT ONE:                 Corporate

JOB CODE: SH1175

JOB FAMILY:                  Corporate Quality

BUSINESS UNIT

(COMMERCIAL ONLY):  

REPORTS TO: Director/Senior Director, Corporate Quality Relationships

JOB SUMMARY

Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/ GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction.

May develop, manage and support a team to create a Quality to Quality interface across accounts, providing each relationship with a single point of contact for quality related.

JOB RESPONSIBILITIES

General Profile

• Provides quality oversight, support and consultancy for or within accounts, as assigned
• Supports the internal account and/or operational teams on quality delivery and continuous improvement
• Provides quality consultancy and support for project/program/functional/account level quality issues,  audits, and inspections (e.g. support for audit/inspection preparation and response activities and inspection readiness activities) as outlined
• Partners with the responsible person for account management (or key project/account team members) and the customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable.
• Performs complex conceptual analyses to evaluate the state of the quality of the complex projects/program/function or account using key quality metrics and/or key performance indicators obtained from the internal metrics team or other sources for projects/program/function or account
• Investigates quality trends, potential risks and mitigations with key project/program/function and account team members 
• Presents information to key stakeholders, responsible person for account management, key project/account team members and the customer Quality representative, as applicable.

• May have direct management and accountability for CQR Professionals.  Manage performance and remediate performance issues.  Foster growth and development of Direct reports to ensure compliance with policy, procedure and regulatory requirements.  Supports Direct reports related to goal setting, problem resolution and decision making.  Recruit, interview and hire new CQR staff.  Participate in CQR SOP/procedure development, training and implementation.  Participate and/or develop key departmental initiatives

Functional and Technical Expertise

• Requires depth and /or breadth of expertise within discipline and recognized in a function or geographic region
• Provides explanations and information to others on difficult issues
• Acts as a resource for others with less experience
• May coach, provides feedback, and guide others
• Requires supervisory skills and sufficient GxP/ regulatory/ technical/process and business knowledge to provide support to direct reports (as applicable).

Complexity

• Solves complex problems and/or conducts complex analyses and translates concepts into practice
• Identify and support resolution of departmental problems including support of problems outside immediate team (as applicable)
• Decision Making - Makes decisions that impact the function or geography.  Make decisions that impact direct reports based on knowledge and experience (as applicable).  Makes daily operational decisions guided by policies, procedures, and business plan that impact CQR's ability to meet performance objectives (as applicable)
• Influence - Influences complex regulatory, business, or technical issues within a business area and/or function.  Influences others to adopt a different point of view on difficult concepts.  Influences peers and direct management.  Influences internal and external customers.  Serve as a primary resource to direct reports (as applicable)
• Problem Solving - Anticipates and resolves key technical, operational, or business problems that impact function or geography.  Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problems.  Solve days to day resourcing, direct report problems; confers with manager to address more complex problems (as applicable)
• Impact - Drives solutions impacting results within an affiliate, site(s) or function.  Drive solutions for resource, assignment and performance issues (as applicable)
• Customer/External Focus - Builds relationships with internal and external customers and partners.  Interacts with regulators, customers, or other outside stakeholders on business issues.  Assesses and interprets customer’s (internal and external) Quality support needs and proactively develops resourcing strategy with support of Senior Director/Executive Director, CQR (as applicable)
• Project Management - Lead and manage quality focused project/account initiatives, as assigned.  May Lead and/or support departmental or cross functional department quality or projects related quality initiatives
• Accountability and Scope - Accountable for performance of direct reports (as applicable)
• Financial and Resource Management - Forecasts resource needs and manages allocated budget (as applicable)
• Strategic Planning - Develops plans to meet short-term objectives with a time horizon of up to six months (as applicable).  Provides input to CQR Management on the development of CQR plans  (as applicable)

Supervision

• Works with minimal guidance; seeks guidance on the most complex tasks/issues.
• Manages CQR Professionals and Manager, CQR, who exercise some latitude and independence in their assignments.

Other tasks

• Perform other quality-related activities as documented in the Quality Relationship Plan / Quality Agreement and as agreed with the client
• Represent Corporate Quality Relationships, as assigned
• Perform other quality-related activities as directed by management
• This position is client facing
• This position may be responsible for managing employees
• Travel may be required (approximately 25%)

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

University degree and professional experience or equivalent.  Experience in a global clinical research, pharmaceutical, or Biotechnology Company preferred. Thorough knowledge of drug development and ICH GCP Guidelines is necessary. Experience in quality management and/or process improvement is essential. Comfortable working closely with customers. Effective at critical thinking and conflict resolution. Effective strategic planning, communication, written, presentation and analytical skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Experience working in a matrix team environment is preferred.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

JOB SUMMARY Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/ GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction. May develop, manage and support a team to create a Quality to Quality interface across accounts, providing each relationship with a single point of contact for quality related. JOB RESPONSIBILITIES General Profile • Provides quality oversight, support and consultancy for or within accounts, as assigned • Supports the internal account and/or operational teams on quality delivery and continuous improvement • Provides quality consultancy and support for project/program/functional/account level quality issues, audits, and inspections (e.g. support for audit/inspection preparation and response activities and inspection readiness activities) as outlined • Partners with the responsible person for account management (or key project/account team members) and the customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable. • Performs complex conceptual analyses to evaluate the state of the quality of the complex projects/program/function or account using key quality metrics and/or key performance indicators obtained from the internal metrics team or other sources for projects/program/function or account • Investigates quality trends, potential risks and mitigations with key project/program/function and account team members • Presents information to key stakeholders, responsible person for account management, key project/account team members and the customer Quality representative, as applicable. • May have direct management and accountability for CQR Professionals. Manage performance and remediate performance issues. Foster growth and development of Direct reports to ensure compliance with policy, procedure and regulatory requirements. Supports Direct reports related to goal setting, problem resolution and decision making. Recruit, interview and hire new CQR staff. Participate in CQR SOP/procedure development, training and implementation. Participate and/or develop key departmental initiatives Functional and Technical Expertise • Requires depth and /or breadth of expertise within discipline and recognized in a function or geographic region • Provides explanations and information to others on difficult issues • Acts as a resource for others with less experience • May coach, provides feedback, and guide others • Requires supervisory skills and sufficient GxP/ regulatory/ technical/process and business knowledge to provide support to direct reports (as applicable). Complexity • Solves complex problems and/or conducts complex analyses and translates concepts into practice • Identify and support resolution of departmental problems including support of problems outside immediate team (as applicable) • Decision Making - Makes decisions that impact the function or geography. Make decisions that impact direct reports based on knowledge and experience (as applicable). Makes daily operational decisions guided by policies, procedures, and business plan that impact CQR's ability to meet performance objectives (as applicable) • Influence - Influences complex regulatory, business, or technical issues within a business area and/or function. Influences others to adopt a different point of view on difficult concepts. Influences peers and direct management. Influences internal and external customers. Serve as a primary resource to direct reports (as applicable) • Problem Solving - Anticipates and resolves key technical, operational, or business problems that impact function or geography. Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problems. Solve days to day resourcing, direct report problems; confers with manager to address more complex problems (as applicable) • Impact - Drives solutions impacting results within an affiliate, site(s) or function. Drive solutions for resource, assignment and performance issues (as applicable) • Customer/External Focus - Builds relationships with internal and external customers and partners. Interacts with regulators, customers, or other outside stakeholders on business issues. Assesses and interprets customer’s (internal and external) Quality support needs and proactively develops resourcing strategy with support of Senior Director/Executive Director, CQR (as applicable) • Project Management - Lead and manage quality focused project/account initiatives, as assigned. May Lead and/or support departmental or cross functional department quality or projects related quality initiatives • Accountability and Scope - Accountable for performance of direct reports (as applicable) • Financial and Resource Management - Forecasts resource needs and manages allocated budget (as applicable) • Strategic Planning - Develops plans to meet short-term objectives with a time horizon of up to six months (as applicable). Provides input to CQR Management on the development of CQR plans (as applicable) Supervision • Works with minimal guidance; seeks guidance on the most complex tasks/issues. • Manages CQR Professionals and Manager, CQR, who exercise some latitude and independence in their assignments. Other tasks • Perform other quality-related activities as documented in the Quality Relationship Plan / Quality Agreement and as agreed with the client • Represent Corporate Quality Relationships, as assigned • Perform other quality-related activities as directed by management • This position is client facing • This position may be responsible for managing employees • Travel may be required (approximately 25%) QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’) University degree and professional experience or equivalent. Experience in a global clinical research, pharmaceutical, or Biotechnology Company preferred. Thorough knowledge of drug development and ICH GCP Guidelines is necessary. Experience in quality management and/or process improvement is essential. Comfortable working closely with customers. Effective at critical thinking and conflict resolution. Effective strategic planning, communication, written, presentation and analytical skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Experience working in a matrix team environment is preferred.   Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. US ONLY FLSA status: Exempt Years of experience required: 8 years of professional experience Physical Requirements: Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person. Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role. Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/ GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction. May develop, manage and support a team to create a Quality to Quality interface across accounts, providing each relationship with a single point of contact for quality related.