SUMMARY/JOB PURPOSE:
The Compliance QA Director for Inspections is accountable for providing the strategy and direction and is responsible for leading and managing the Inspection Readiness program for GxP-regulated areas, including systems managed by external vendors. This role ensures company-wide departmental inspection readiness via interaction with stakeholders, develops inspection readiness scorecards and that the company is inspection-ready at all times, per current industry inspection trends. This individual will establish company processes to identify and manage compliance risks, mitigate and appropriately escalate issues in a timely manner, and capture risks in a risk log so that weak signals are captured to full awareness. Building strong relationships with internal stakeholders is vital to this role.
The Compliance QA Director will serve as the QA Partner (Primary Point of Contact) and be the voice of Quality for Exelixis business stakeholders. This individual will represent QA in an outwardly and business-facing capacity in strategic and decision forums and triage communication between Exelixis business functions, internally or externally, and QA to provide and ensure delivery of company core goals and pipeline deliverables.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manages the implementation, maintenance, and execution of the Exelixis Inspection Readiness program, including the creation of an inspection readiness scorecard across all GxP functions.
- Manages company Inspection Management activities and sets the strategic plan for maintaining organizational inspection readiness at all times across all organizational functions in all stages of development, clinical or commercial product, and support.
- Maintains the inspection opening presentation materials and logistics, to ensure consistency and current content.
- Manages all internal logistics (front and back-room) for GxP Inspections or Audits of Exelixis.
- Provides inspection-related company-wide training.
- Partners with stakeholders, including Pharmaceutical Operations and Supply Chain, R&D (Biologics and CMC), Product Development, Clinical Operations, Regulatory Affairs, Global Patient Safety, Non-clinical Development, etc., regarding inspection preparedness, compliance assessments, including identifying and mitigating compliance gaps, and provides compliance guidance related to GxP processes.
- Monitors current regulatory requirements, timely informs stakeholders of the potential impact on the organization or related systems and initiates a gap assessment as necessary.
- Serves as the Compliance QA Partner for inspection-readiness related to quality issues, initiatives, and projects.
- Responsible for developing, tracking, and reporting compliance and inspection metrics and escalating trends or significant findings to company management.
- Assesses proposed corrective or preventive actions in response to audit or inspection findings, tracks and reports item closures, and timely escalates areas of risk or concern.
- Oversees continuous improvement of Inspection Readiness processes and activities, including policies, procedures, and training.
- Responsible for inspection record archival and maintenance in eQMS.
SUPERVISORY RESPONSIBILITIES:
- None.
- Indirectly leads cross-functional teams, as required.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- BS/BA degree in Biology, Sciences, or related discipline and a minimum of 13 years of related experience; or,
- MS/MA degree in Biology, Sciences, or related discipline and a minimum of 11 years of related experience; or,
- PhD degree in Biology, Sciences, or related discipline and a minimum of 8 years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
- Experience in the biotech or pharmaceutical industry managing Health Authorities during inspections and managing Customer/Business Partners during inspections is required.
- Experience managing the FDA's Bioresearch Monitoring (BIMO) program inspections is preferred.
Knowledge/Skills:
- Applies a wide range of knowledge of the biotechnology/pharmaceutical sector to perform complex work and demonstrates influence beyond QA.
- Makes decisions on complex issues using strategic and critical thinking skills.
- Requires a broad range of knowledge of biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.
- Demonstrates strong organizational and planning skills to creatively analyze and improve processes and set standards for high-quality work.
- Possesses authoritative, effective, and adaptable communication skills (verbal, written, and presentation) to facilitate critical discussions.
- Fosters collaboration amongst teams and stakeholders and can achieve mutual trust and alignment in order to deliver on goals.
- Demonstrates the ability to provide indirect leadership and guidance to QA, partners, and key stakeholders.
- Withholds judgment to address conflict in a positive manner by acknowledging dissenting opinions and identifying options to achieve an equitable solution.
- Models team spirit, culture, and ethics.
- Leads indirectly through ambiguity and change.
- Develops talent through mentoring and coaching.
- International/global experience preferred.
- Understands technical information related to equipment, processes, and regulatory expectations.
- Interprets regulatory standards and ICH guidelines.
- Provides insight into current processes and recommends modifications to corporate procedures.
- Experience in a virtual manufacturing environment, including small molecule and oral solid dosage form; knowledge of large molecule and biologics is preferred.
- Uses broad expertise or unique knowledge and skills to drive and deliver on company core objectives, and achieve goals with measurable impact and outcomes.
- Demonstrates a high level of independent quality judgment and acumen.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address cross-functional project level challenges, taking into consideration the broader impact.
- Engages, influences, and collaborates with stakeholders on cross-functional projects.
WORKING CONDITIONS:
- This is an onsite position (Monday through Friday).
- Travel to key sites as required.
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.
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