Technical Quality Manager Job

Company Name:
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.

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Senior Manager, Technical Documentation
San Francisco, CA Salesforce.com, Inc
Senior Quality Agreements Compliance Manager
San Mateo, CA proclinical
Lead Technical Recruiter/ Delivery Manager
San Jose, CA Flexton Inc.
PW4000 Technical Manager
San Francisco, CA United Technologies Corporation
Program Executive Office Integrated Warfare Sy...
San Diego, CA SAIC
Manager, Technical Writing
Mountain View, CA Google