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Description:
• Ensures site quality oversight of commercial and/or development products at CMO’s.• Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions.• Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on development programs.• Ensures that performance and quality of drug products conforms to established standards and regulatory requirements.• Assure CMO’s meet Gilead quality regulatory and compliance standards in order to ensure a sustainable delivery of quality product to patients and maintains a good working relationship.• Reviews regulatory documents and provide expertise and guidance in interpreting governmental regulations agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections.• Collaborates engages and works cross functionally with other Quality groups.• Acts as an escalation contact for complex and high impact quality issues concerns and decisions.• Leads/coordinates investigations and the development and implementation of corrective and preventative action (CAPA)• Quality risk management identifying key risks impacting commercial and development programs• Competent in execution and responsible for translating quality strategy into plans of actions• Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the functions to respond accordingly• Participates in developing controlled documents (e.g. SOPs, validation etc.)
Additional Skills & Qualifications:
Technical skills:Aseptic mfg expExperience in pharmaceutical mfgRoutine skills with quality systemsExcel4-5 years of relevant experience. VeevaVault quality systems experience; or any other quality system TrackWise, MasterControl.QA role that deals internally would be ok. Does not need to be CMO specific.Degree is open.Product knowledge – sterile mfg, aseptic – FDA and European regulations.
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
