Job Description
Title: Director, Quality Assurance, PharmaLocation: Redwood City, CA (hybrid model)Type of role: FTE, Full time Salary: plus bonus and equityOur start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate will be a hands-on Director who brings broad QA experience in the biologics industry.Job Description
- Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidance
- Review all GXP documents/reports especially as they relate to method development, validation activities and PPQ generation results
- Provide compliance oversight for internal and contracted external GXP activities
- Coordinate and implement audit plans and audit reports for all CROs, CDMOs, and GMP vendors and internal departments.
- Coordinate and perform virtual or on-site audits as needed
- Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
- Lead and ensure inspection readiness activities for all internal and external entities
- Host GMP inspections. Follow up to any responses and CAPAs
- Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems
- Develop and implement overall GXP strategy, performance metrics, analytics, and reports
- Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical setting.
- Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.
- Experience in designing and implementing quality systems and risk management tools
- Experience interacting with and managing CMOs for DS and DP especially biological products
- Experience leading/hosting US and international health authority inspections/interactions
- Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
- Must demonstrate high organizational, prioritization and management proficiencies
- Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
Numbers & Facts
| Location | Redwood City, California |
| Industry | Computer/IT Services |
| Company Size | 50 to 99 employees |
| Year Founded | 1999 |
| Website | http://www.adeptsource.com |
About Company
With offices throughout northern and southern California and administrative offices near Austin, Texas, AdeptSource provides industry specific IT professionals on a temporary or full-time basis to biotech customers nationwide. We also provide Professional Services and Managed Services on a project basis. Our extensive background, technical expertise, and excellent reputation demonstrate our ability to consistently deliver results to our partners. AdeptSource is your partner in finding and evaluating top talent to help you achieve your IT staffing goals. In a seemingly endless pool of IT professionals, we provide quality candidates on-time and with less expense. Spend less time vetting potential candidates and more time focused on achieving your IT goals.
At AdeptSource, we provide biotech customers with talented IT professionals of all types who possess multi-level experience and specialized skills in an exceptionally wide variety of industries, platforms, languages, and development tools. Why use AdeptSource?....
- The deep technical knowledge and vast experience of our recruiting team delivers significant value to clients, making AdeptSource your ideal business solutions partner.
- Our organization is divided into specialized solutions groups. Our focus on delivering solutions for industry specific needs guarantees the right expertise of every AdeptSource staff member and consultant on every project.
- We are proud to provide consulting support and a true busines spartnership to our client, combined with high standards and business ethics, without the traditional sales pressure.
- We have a heart for needy children, which is why we are committed to doing something about it. For every candidate we help our clients hire, AdeptSource sponsors a child through our corporate partnership with Arms of Love International.
Skills
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