Executive Director, GCP Quality Assurance

SUMMARY/JOB PURPOSE:

The Executive Director, GCP/GVP QA, is accountable and responsible for defining and implementing an end-to-end GCP/GVP QA strategy and direction, as well as implementing and maintaining an effective cross-functional GCP/GVP Inspection Readiness program. This position leads and develops a team of GCP QA professionals and collaborates with functional embedded compliance roles to assess company compliance and quality across GCP and GVP functions, systems, and activities.

Integrates quality by design throughout functional and cross-functional GCP and GVP processes, and a risk-based approach to associated audits; supports cross-functional Quality Risk Management (QRM) processes to identify, track, and mitigate risk within GCP/GVP, develops, tracks, and trends key metrics to inform risk-based decisions, and collaborates with functional representatives to manage patient safety and clinical data integrity and reliability risks through support of functions and QA oversight activities.

In addition, this position drives GCP/GPV Inspection Readiness initiatives internally and serves as the coordinator for the Inspection Readiness Governance Council (IRGC), partners with clinical study teams and CROs to conduct inspection preparation activities at Clinical Sites, and collaborates with Compliance QA on the conduct of GCP/GVP mock inspections, internal, and clinical site audits. Manages regulatory health authority clinical trial-related sponsor inspections, primarily as a moderator.

Identifies and resolves issues for continuous improvement, in strong partnership with internal functions (e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Global Patient Safety, Clinical Data Management, Biostatistics, and clinical study teams) and external partners. Delivers training and provides feedback to cross-functional subject matter experts (SMEs) on how to perform and respond to questions or requests during an inspection.

Aligns key GCP/GVP QA strategies with business goals and understands the global regulatory compliance landscape and how that translates to regulatory expectations in the context of inspection management. Represents QA as the QA Partner (Primary Point of Contact) responsible for building and maintaining solid relationships with functional leaders and other key stakeholders, speaking One Voice for Quality, and represents QA in an outwardly and business-facing capacity, in strategic and decision forums, to provide and ensure delivery on company strategic goals and deliverables.

Delineates and communicates roles and responsibilities clearly and effectively, manages communications in a productive and transparent way, and leverages established relationships to influence behavior across the organization. In the context of clinical sponsor inspections, serves as the GCP/GVP moderator who can respond to first-level questions, triage questions and requests to the appropriate SMEs, manage complex questions, defend company processes and positions properly, and facilitate a smooth inspection process with successful outcomes.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Establishes and maintains the GCP/GVP Inspection Readiness program and supports the development and revision of functional and cross-functional policies and procedures.
• Supports auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines.
• Responsible for the overall health of the GCP/GVP Inspection Readiness program, collaborating with cross-functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks.
• Develops QA GCP/GVP strategy for team within QA with clear goals and objectives that align with business needs; manages complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives for resolution.
• Partners with Compliance QA on Clinical Site Audits; uses the outcomes to inform risk-based decisions and development or refinement of metrics designed to identify potential noncompliance at Exelixis-sponsored clinical trial sites.
• Assesses new regulations and guidances to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered.
• Oversees and coaches GCP/GVP QA team members through regular individual touchpoints and team meetings.
• Develops a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability.
• Serves as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance.
• Reviews and approves, as applicable, non-clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable.
• Partners with key stakeholders, including Clinical Operations, to define functional and QA oversight of the CROs and other critical vendors.
• In partnership with functional stakeholders, identifies and manages issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties.
• Interprets and applies ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol, informed consent, and protection of confidentiality of the test subject, and quality assurance in clinical trial management.

SUPERVISORY RESPONSIBILITIES:

• Leads a team of GCP/GVP quality professionals.
• Leads a cross-functional team, the IRGC.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Education/Experience:

• BS/ B.Sc preferably in the life sciences or STEM disciplines and a minimum of 18 years of related experience; or,

• MS/M.Sc. preferably in the life sciences or STEM disciplines and a minimum of 16 years of related experience; or,

• PhD preferably in the life sciences or STEM disciplines, and a minimum of 15 years of related experience; or,

• Equivalent combination of education and experience.

• Knowledge, Skills and Abilities:

• Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 22 years' experience in the biotech, pharmaceutical, or related industry

• Typically requires a minimum of 10 years of people management at various levels of the management (direct or indirect)

• Demonstrated knowledge of GCP, GVP, and Quality Systems

• Requires a broad range of knowledge and experience with clinical trial conduct and international regulations

• Experienced in hosting regulatory inspections, presenting or defending functions in internal audits or audits by business partners, clinical site audits, and regulatory inspections

• International/global experience preferred

• Experience in auditing is preferred

• Proven leadership, organizational, and management skills to coordinate multi-disciplinary groups, ability to manage complex issues, sound decision-making, and strategic planning skills, develops company objectives and principles, and achieves goals with measurable impact and outcomes

• Qualified QA professional, with a broad range of knowledge and experience with global clinical trials and related GCP/GVP processes, as well as global QA and regulatory compliance

• GCP/GVP. Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results

• Ensures successful completion of major programs, projects, and/or functions

• Has a solid understanding of peer company best practices with respect to clinical trial execution and is able to review existing processes and refine or improve them over time

• Knowledge/Skills:

• Deep knowledge and understanding of GCP and GVP in the context of clinical trials drug development process and GxP Global Regulatory Requirements

• Uses broad expertise or unique knowledge and skills to deliver on company goals and priorities with measurable impact and outcomes

• Ability to influence decision makers, utilizing sound problem-solving skills to recommend and implement feasible solutions

• Skilled leader of inspection readiness GCP/GVP working groups

• Excellent written, oral, and presentation communication skills, able to translate complex concepts across all levels of the organization

• Applies analytical thinking to develop technical and/or business solutions to complex problems

• Drives for results

• Hires strong talent and engages the team by providing training and guidance to drive for measurable results

• Proven leader with demonstrated ability to build and lead successful teams

• Strong collaboration skills, demonstrated ability to lead through change, and identify opportunities that result in positive business outcomes

• Excellent organizational agility and project management skills; gets results while strengthening internal and external relationships

• Consistent demonstration of making timely decisions without complete data to ensure quality product to patients; sound quality judgement and balance between business, supply, and quality

• Highly skilled in working with ambiguity and complexity; continuously modifies options and solutions across all levels of the organization

JOB COMPLEXITY:

This role requires a skillset that includes the ability to lead change by engaging others, assessing unforeseen situations, and continuously learning to achieve a goal. This role is critical to the success of the companys core deliverables and requires continuous communication to maintain alignment across the organization. This role requires management of multiple competing priorities, and the ability to evaluate data to detect weak signals, blind spots, and escalate cumulative risks.

WORK ENVIRONMENT/PHYSICAL DEMANDS:

Our office is a modern, open-planned space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. Travel as required (20-30%). This position is onsite at our Alameda, CA headquarters.

DISCLAIMER:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class