Sr. QA Compliance Manager
Proclinical is currently recruiting for a Sr. QA Compliance Manager for a leading pharmaceutical company located in the Southern San Francisco, CA. Successful candidate will have stakeholder engagement, global supplier management, and data analysis experience with at least 7 years of experience.
- Define and develop a global supplier management process.
- Define and develop a vendor selection process.
- Assist with supplier qualification activities of new and existing suppliers in support of clinical and commercial manufacturing activities.
- Manage supplier changes and risk evaluation activities; examples of changes include supplier onboarding, supplier inactivation, change in material/services provided, name and location.
- Proactively communicate supplier changes within SMA that impact activities such as QP release, audit scheduling, Quality Agreements, etc.
- Ensure Approved Supplier List is maintained and managed in Oracle Agile.
- Perform data analysis to report inspection trends in the industry and CXOs to support supplier oversight and inspection readiness activities.
- Engage with cross-functional stakeholders in Foster City (Quality Assurance, Development/Manufacturing, Packaging/Labeling, Supply Chain, Analytical Operations, Outsourcing) and other internal sites (Alberta, Cork, Oceanside, San Dimas, La Verne).
- Gain expertise and be proficient in relevant electronic systems (e.g. Oracle Agile, Trackwise, VeevaVault).
- Identify and drive continuous improvement initiatives.
- Other responsibilities as required to meet business needs.
Skills and Requirements:
- 7+ years of experience of relative experience.
- Strong working knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks.
- Experience with supplier management and auditing.
- Demonstrate a thorough knowledge of compliance requirements and an understanding of current global and regional trends.
- Thorough knowledge of and competence in core quality processes such as deviations, CAPA management and change control.
- Excellent communication skills including ability to effectively speak with courage and candor across organizational levels and functions.
- Able to interpret problems and effectively prepare surrounding communication in a productive manner to key stakeholders with clarity, brevity, and accuracy.
- Charismatic leader with strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders.
- Able to maintain a balance between being strategic/big-picture thinker and taking deeper tactical dives as needed.
- Excellent project management skills.
- Demonstrated ability to perform in a fast-paced environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.