Associate QA Operations Director - Systems and Process

Exelixis Inc; Alameda (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Exelixis Inc in Alameda, California, is seeking an Associate QA Operations Director to provide quality assurance leadership for labeling and systems. The role requires extensive experience in the pharmaceutical industry, ensuring compliance with quality standards and managing complex quality events.

Key responsibilities include overseeing deviation management and ensuring the effectiveness of quality systems. The ideal candidate will possess a strong educational background in Biology or related fields and have a proven track record in risk management and regulatory compliance.

Qualifications

• 11 years of related experience in QA operations or 9 years with a Master's degree.
• Experience in biotech or pharmaceutical industries with a focus on packaging/labeling.
• Strong knowledge of cGMPs and Health Authority Regulations.

Responsibilities

• Lead QA support for deviations and change control management.
• Provide guidance on quality systems usage and best practices.
• Perform clinical and commercial labeling review and approval.

Skills

Quality Systems Management

Risk Management

Regulatory Compliance

Pharmaceutical Industry Knowledge

Project Management

Education

BS/BA in Biology or related field

MS/MA in Biology or related field

Job description

Overview

SUMMARY/JOB PURPOSE The Associate QA Operations Director – Labeling & Systems is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). Partners closely with QA and cross-functionally with Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) as needed to identify, mitigate, escalation, and resolve issues and risks. This role supports development, generation, review, and approval of clinical and commercial artwork and labeling. Demonstrates a high level of independent quality judgment and acumen.

Responsibilities

• Lead and partner QA support for deviations, change control, CAPA, CAPA actions, and effectiveness checks management.
• Provide guidance on quality systems usage, process requirements, best practices, and record completeness.
• Provide QA oversight of Veeva periodic enhancements (quarterly and annually).
• Provide cross‑functional guidance on deviations, change requests, CAPA, effectiveness checks, and associated actions, supporting complete, thorough, and timely completion of the quality records.
• Track and trend supported systems, provide metrics for Quality Systems Management Review (QSMR).
• Provide monthly Veeva quality event status reports to QA and functional areas, proactively driving timely record closure.
• Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues.
• Deliver on company core objectives in a timely manner, per supply plan, and drive for results.
• Lead process and system improvement.
• Generate a risk‑based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement, ensuring compliance with global regulatory standards, and aligning with key stakeholders.
• Resolve quality issues, identify and mitigate risk, propose options and solutions, and escalations.
• Serve as SME for Health Authority inspections and audits.
• Establish and maintain strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.
• Foster collaboration within QA and stakeholders, to gain mutual trust, achieve alignment and solve problems.
• Manage conflict by engaging teams to address issues, seeking diverse views and facilitating the identification of options to achieve an equitable solution.
• Drive results and influence others outside of direct authority.
• Manage objective setting and balancing commitments to prioritize and complete activities within established timelines.
• Perform other duties as assigned.
• Comply with all policies and standards.

Travel Requirements

10% travel time required for this position.

Qualifications

• Education: BS/BA in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or MS/MA in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or an equivalent combination of education and experience.
• Experience: Background in the pharmaceutical or biotech industries with packaging/labeling preferred; development of business strategies, metrics, and continuous improvements; proven indirect organizational and management skills; ability to manage complex issues; sound decision‑making and strategic skills; demonstrated knowledge of cGMPs, Health Authority Regulations, quality systems and manufacturing processes; international/global regulatory requirements experience preferred; participation in regulatory inspections and audits.
• Knowledge, Skills & Abilities: Apply wide range of biotechnology/pharmaceutical knowledge to perform complex work; provide input beyond the QA function and propose solutions to highly complex issues; understand technical information related to equipment, processes, and regulatory expectations; strong time‑management and organizational ability; learn to analyze and improve processes; excellent written, verbal and presentation communication skills; proven ability to manage multiple competing priorities; evaluate data to detect weak signals, blind spots and rapidly escalating cumulative risks; lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve goals, and drive for results.

Employment Practices

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.