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Technical Quality Manager Job

Company Name:
Arca24.com
Salary period: Annual
Senior Technical Manager - Product Quality Review needed for a contract opportunity with Yoh's client located in South San Francisco, CA.
The Big Picture
Work closely with global internal and external sites and other corporate technical and Quality data contributors and senior level management (including Quality site heads) to author End-to-End Annual Product Quality Review reports.
Top Skills You Should Possess:
- Quality/Compliance
- Report Writing
- cGMP
- Quality systems
What You'll Be Doing:
- Perform the end-to-end (E2E) Annual Product Quality Review for commercial products. The process requires input from site APQR modules from the entire global supply chain including CMOs and global Quality functions for cross-site and end-to-end reviews, analysis for trends and issues required to assess the overall state of control for the manufacturing process and product quality and if necessary, recommend appropriate actions.
- Contribute to the performance metrics and overall product Quality assessment and reporting as part of the APQR business process.
- Identify and communicate issues in process and/or product quality including analytical control systems.
- Initiate APQR action items and ensure the appropriate quality system elements are deployed as outcomes of the APQR action items.
- Perform assigned tasks in compliance with global health regulations and policies and procedures.
- Applies knowledge of global regulatory requirements and guidelines pertaining to APQR and related areas.
- APQR work is performed under limited direction.
- Proactively escalate potential product quality and compliance issues with proposed solutions.
- Develop and implement quality initiatives and solutions to problems in consultation with management.
What You Need to Bring to the Table:
- A, B.S. or higher degree (preferably in a Life Science or Engineering) and at least eight (8) years of experience in the pharmaceutical, biopharmaceutical, or related industry.
- Work experience in Quality, Pharmaceutical Manufacturing or Process Development.
- Extensive knowledge of cGMPs, health authority regulations, and quality system requirements.
- In depth technical expertise in drug substance and drug product manufacturing processes and associated control systems.
- Knowledge of devices and device development requirements is desirable.
- Excellent communication and organizational skills.
- Proactive in taking initiative and responsibility.
- Demonstrated ability to build strong personal relationships.
Opportunity is Calling, Apply Now!
Recruiter: Hannah Cihlar
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
J2W: CLINICAL
MONJOB
J2WSWSCI
Ref:
SFSF: LS

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