Operations QA Manager - Commercial

Regulatory Toolkit; Alameda (CA); On-site; USD 145,000 - 183,000; Full time

Benefits offered by this job

401k plan

Comprehensive medical/dental/vision

Discretionary annual bonus

Stock purchase program

Job summary

Exelixis is seeking an Operations QA Manager - Commercial to lead QA oversight of GMP operations across CMOs handling Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling in Alameda, CA.

You will assess vendor processes, review batch records, and escalate risks to products while ensuring compliance with US/EU regulatory requirements. Strong leadership, documentation and communication skills are essential for this role.

Qualifications

• BS/BA in related discipline with a minimum of 7 years of related experience; or, MS/MA with 5 years; or PhD with 0 or more years; or equivalent.
• Experience in biotech or pharmaceutical industry is required; CMO oversight preferred.

Responsibilities

• Develop QA programs to ensure GMP compliance of commercial and clinical materials.
• Perform record review and disposition for commercial and clinical materials including QA assessments.
• Coordinate investigations with vendors and interdepartmental teams for quality issues.
• Oversee generation, review, and approval of GMP documents.
• Support QA partners to manage vendors, contract facilities, and joint development collaborators.
• Support implementation of quality systems and regulatory guidance.

Skills

QA oversight

Regulatory knowledge

Analytical skills

Business communication

Microsoft Office

Documentation review

Vendor management

GMP compliance

Project leadership

Biotech knowledge

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Equivalent combination of education and experience

Tools

Word

Excel

PowerPoint

Job description

SUMMARY/JOB PURPOSE:

The Operations QA Manager - Commercial is responsible for the QA oversight of end-to-end, day-to-day GMP Operations at the Contract Manufacturing Organizations (CMOs) that generate Exelixis products, including Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling.

Assesses vendor processes, systems and procedures to evaluate their quality performance against established standards and regulatory requirements. Reviews batch records. Part of Exelixis partnerships and collaborations to identify, rapidly mitigate and **escalate** risks to products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops, establishes and maintains the QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material.
• Performs record review, and disposition activities for commercial and clinical trial material including conducting the comprehensive QA assessment.
• Coordinates investigations with vendors and interdepartmental teams to resolve potential product quality issues.
• Oversees the generation, review and/or approval of internal and external documents used in GMP activities.
• Provides support to the QA Partner to manage vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Supports the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GMPs.
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Assists in monitoring current and proposed quality and scientific issues and advises supervisor on events for Exelixis.
• Provides support as needed for the review various quality review/approval documents such as, but not limited to, manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Authors work instructions and standard operating procedures.
• Drives for results

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 7 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 5 years of related experience; or,
• PhD in related discipline and 0 or more 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 is required.
• Experience in CMO oversight is preferred.

Knowledge/Skills:

• Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
• Has extensive experience in a virtual manufacturing environment or relevant industry/profession.
• Small molecule technical knowledge, oral solid dosage form and biologics preferred.
• Familiarity with serialization is desired.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Develops technical 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.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Excellent verbal, written and presentation communication skills.
• Must be proficient in Word, Excel and PowerPoint.

WORKING CONDITIONS:

• Onsite position
• Travel as required

#LI-HG1

Location: Alameda, CA Range for this position: $145,000 - $183,000 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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.