Associate QA Systems and Process QMS Director

Exelixis•Alameda, CA

About The Position

The Associate QA Systems and Process QMS Director is the QA lead accountable for organizational guidance and support for Quality Management Systems (QMS), and acts as the business owner to ensure fit-for-purpose, compliant, and timely execution of complex quality events. The role owns continuous QMS improvement through process enhancements, training, metrics reporting, and eQMS business ownership. It partners with QA and cross-functional teams—including Pharmaceutical Supply Chain, Clinical Development and Operations, IT, Regulatory Affairs, and Global Patient Safety—to identify, escalate, and mitigate issues and risks. The role owns the Change Control process and eQMS business process, provides QA oversight of Veeva enhancements, and maintains governing procedures. It drives cross-functional compliance and continuous improvement, tracks and reports QMS metrics, and supports timely completion of quality records. The position also develops risk-based strategies across the GxP landscape, improves eQMS and Computer System Validation processes, resolves and escalates quality issues, and serves as a subject matter expert during health authority inspections and audits. It may back up other QMS QA leads and support CSV and Data Integrity QA activities as needed. The position has no supervisory responsibilities and requires up to 10% travel.

Requirements

BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or a related discipline, with 11 years of related experience; or an MS/MA degree in one of these fields or a related discipline, with 9 years of related experience; or an equivalent combination of education and applicable experience.
Broad knowledge of the biotechnology or pharmaceutical sector to perform complex work, contribute beyond the QA function, and propose solutions to highly complex issues.
Demonstrated knowledge of cGMPs, health authority regulations, quality systems, and manufacturing processes.
Ability to understand technical information related to equipment, processes, and regulatory expectations.
Strong time-management and organizational skills, including the ability to analyze and improve processes and consistently produce high-quality work.
Excellent written, verbal, and presentation communication skills, including the ability to explain complex concepts across all levels of an organization.
Ability to manage competing priorities, evaluate data for weak signals, and escalate cumulative risks.
Ability to lead through change by engaging others, assessing unforeseen situations, continuously learning, achieving goals, and driving results.
Ability to travel up to 10%.

Nice To Haves

Experience in the pharmaceutical or biotechnology industries and in Quality Systems.
Experience developing business strategies, metrics, and continuous improvements.
Proven indirect organizational and management skills, ability to manage complex issues, sound decision-making, and strategic skills.
Experience with international or global regulatory requirements.
Experience participating in regulatory inspections and audits, including presenting or defending functions.

Responsibilities

Provide QA support and guidance for QMS processes, including Deviations, Change Control, CAPA, CAPA Actions, and Effectiveness Checks.
Own the eQMS business process and serve as QMS Business Owner.
Guide users on QMS use, process requirements, best practices, and record completeness.
Provide QA oversight of Veeva periodic enhancements.
Drive cross-functional compliance and ensure complete, thorough, and timely completion of quality records.
Own governing procedures and drive continuous improvement to maintain fit-for-purpose, risk-based QMS processes.
Track and trend QMS performance and provide metrics for Quality Systems Management Review.
Provide monthly Veeva quality-event status reports to QA and functional areas and proactively drive timely record closure.
Develop and champion risk-based strategies across the GxP landscape to identify, manage, and mitigate risks, address blind spots, escalate issues, propose solutions, drive improvement, and align with stakeholders and global regulatory standards.
Lead continuous improvement of the eQMS platform and Computer System Validation processes to improve efficiency, compliance, and system effectiveness.
Resolve quality issues, identify and mitigate risks, propose options and solutions, and escalate as needed.
Serve as the subject matter expert for health authority inspections and audits, and foster stakeholder relationships to support timely documentation, escalation, and resolution of quality issues.
Manage conflict by engaging teams, seeking diverse views, and facilitating options for equitable solutions.
Drive results and influence people outside direct authority.
Set objectives and balance commitments to prioritize and complete activities within established timelines.
Back up other QMS QA leads and support CSV and Data Integrity QA activities as needed.
Perform other duties as assigned and comply with all policies and standards.

Benefits

401(k) plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Eligibility for a discretionary annual bonus program, or a sales-based incentive plan for field sales staff.
Opportunity to purchase company stock and receive long-term incentives.
15 accrued vacation days in the first year.
17 paid holidays, including a company-wide winter shutdown in December.
Up to 10 sick days throughout the calendar year.
Accommodation support for applicants with disabilities during the recruiting process.