Executive Director, Clinical Quality Assurance (GCP) Details

Executive Director, Clinical Quality Assurance (GCP)

Exelixis - Alameda, CA

Employment Type : Full-Time

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

The Executive Director is responsible for partnering with Clinical Operations to set the strategy which ingrains Quality and Compliance across all the GCP systems and activities, engaging a team of dedicated staff to identify and drive continuous improvement, and is an active member of the Quality Team. This role is instrumental in integrating quality throughout all steps of the GCP process, monitoring and auditing using risk assessments and tracking and trending the key metrics to drive improved compliance and quality of the GCP activities. This leader will also generate an audit schedule, perform audits and lead a team of quality professionals. This position reports to the Vice President of Quality Assurance and is a member of the Quality Assurance Leadership Team, driving functional and cross-functional projects that embed continuous improvement principles across the company. These responsibilities involve working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Legal, and other teams across Exelixis.

Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for one or more of the following areas: establish and maintain the GCP QA programs, policies, and procedures; ensure cGCP compliance of clinical trials.
• Act as the primary business partner with internal Development organizations including Clinical Operations, Clinical development, and Clinical Supply Chain.
• Act as the primary contact for vendors, contract facilities and contract service providers.
• Oversee and manage the auditing process and other GCP QA inspectional activities.
• Ensure compliance with applicable health authority regulations and guidelines for document management and software used in GCP processes.
• Responsible writing and maintaining GCP SOPs as required.
• Understand and interpret regulatory agency policies and guidance as it pertains to GCP requirements.
• Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.
• Responsible for inspection readiness related to GCP and is the primary liaison with Health Authority and Partners during internal audits and Health Authority inspections
• Conducts audits at Clinical Trial Sites, and Contract Research Organizations to ensure the compliant conduct of Exelixis Sponsored clinical trials.
• Monitors current and projected quality issues and advise management on events of significance for Exelixis’ business interests.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises a team of Quality professionals
• Develops talent, including development planning, cross training and auditor training.
• Indirectly leads staff through cross functional committees or team

EDUCATION/EXPERIENCE/SKILLS:
Education:

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, engineering, industrial engineering or a related field and 18 years of related experience.

Experience:

• Minimum of 18 years of relevant experience in pharmaceutical/biotech
• Minimum of 10 years GCP Quality Assurance experience
• Minimum of 7 years in a leadership role with demonstrated management skills and business acumen
• Experience in developing business strategies, metrics, and continuous improvements
• BioTech/Pharmaceutical industry experience preferred.

Knowledge/Skills/Abilities:

• Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP, and GCP in particular.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals with measurable impact and outcomes.
• Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.
• Applies strong analytical thinking to develop technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Hires great talent and engages their team by providing training and guidance to generate exceptional results that are impactful and measurable.
• Interprets, executes and recommends modifications or additions to company policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.

JOB COMPLEXITY:

• This role requires a skillset that includes the ability to lead change by engaging others, assessing unforeseen situations, failing fast and continuously learning to achieve a goal.
• This role is critical to the success of the clinical program 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.

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Additional Information

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.