5 days old

Executive Director, Quality Compliance

Exelixis Inc
Alameda, CA 94501
  • Job Code
    743999751935120
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

This energetic and engaging leader will provide an end-to-end strategy to assure quality compliance for the company. The successful candidate would apply Quality Risk Management (QRM) appropriately, creating risk scorecards that drive continuous improvement priorities. The successful candidate will lead a team responsible for several key areas, including Inspection Readiness, the Internal/External Audit program, Vendor Quality Oversight, and Product Complaints. These activities require strong partnerships with internal and external partners to discuss issues and seek continuous improvement. The successful candidate would also align key Quality initiatives and strategies with key business goals with an understanding of the global quality landscape as it relates to regulatory compliance. The successful candidate will represent Quality on the appropriate teams as the Single Point of Contact and speak with the One Voice for Quality. This leader would be responsible for identifying issues and risks in a product quality risk log so that weak signals are captured, and full awareness of the risks are escalated appropriately.

This position required a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsible for overall health of Quality Compliance, identifying Quality issues and risks, and creating an overall scorecard that can be applied to manage quality risks.
Responsible for Inspection Management process.
Ensure an overall state of compliance, looking end to end across all of Quality functions.
Define, execute, and constantly improve the GxP policies and procedures.
Ensure Quality Technical Agreements are in place and maintained per procedure to maintain proper oversight on CMOs, vendors, and development collaborators.
Partner with key stakeholders to define the Quality oversight of the vendor management program.
Assure adherence to schedule for the internal and external audit programs.
Provide guidance on the continued development of our Product complaint process.
Identify key product quality risks and bring full awareness of the risks, including weak signals and potential blind spots.
Interpret and apply applicable 21CFR, USP, EP, JP, and ICH regulatory guidelines and directives.
Provide technical expertise and leadership as required and provide recommendations and influence global issues.
Demonstrated ability to provide leadership and guidance across all levels in the company

SUPERVISORY RESPONSIBILITIES:
Leads a team of quality professionals.
Could also lead a cross functional team as required.

EDUCATION/EXPERIENCE/SKILLS:

Education:
BS/ B.Sc preferably in the life sciences or STEM disciplines and 18 years of related experience, or;
MS/M.Sc. preferably in the life sciences or STEM disciplines and 16 years of related experience, or;
PhD preferably in the life sciences or STEM disciplines and 14 years of related experience.

Experience:
Typically requires a minimum of 22 years' experience in 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 cGMPs, Health Authority Regulations, Quality Systems and technical expertise in DS/DP/FG manufacturing processes.
International/global experience preferred.
Experience in auditing is desirable.
Proven leadership, organizational and management skills to coordinate multi-discipline groups.
Ability to understand technical information related to equipment, processes, and regulatory expectations.
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Understanding and familiarity with worldwide Health Authority requirements and associated industry guidelines.

Knowledge/Skills/Abilities:
Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP.
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 analytical thinking to develop technical and/or business solutions to complex problems.
Hires great talent and engages their team by providing training and guidance to generate exceptional results that are impactful and measurable.
Proven leader with demonstrated ability to build and lead successful teams.
Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.
Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships.
Consistent demonstration of managerial courage to make timely decisions without complete data to ensure quality product to patients.
Consistently demonstrates sound quality judgement and balances between business, supply and quality aspects.
Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
Travel to key sites as required.

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.

#LI-HG1

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.





Posted: 2021-06-08 Expires: 2021-07-07
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Executive Director, Quality Compliance

Exelixis Inc
Alameda, CA 94501

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