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Technical Manager, Ext Quality Job

Company Name:
Arca24.com
Salary period: Annual
Technical Manager, Ext Quality needed for a contract opportunity with Yoh's client located in South San Francisco, CA
Top Skills You Should Possess:
- CAPA
- raw material
- cGMP, GLP, GCP
What You'll Be Doing:
- Follow company policies and procedures.
- Maintain a state of inspection readiness.
- Provide input to the development of personal performance goals and departmental objectives.
- Collaborate with Management to establish and meet targets and timelines.
- Independently manage competing priorities with limited guidance.
- Serve as the Quality representative on cross-functional and multi-site teams.
- Identify, design, and implement process and system improvements.
- Lead and participate in the design and implementation of department and cross-functional initiatives.
- Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems and serve as a technical subject matter expert (SME) in support of department functions.
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Train personnel and internal customers on relevant business processes.
- Sign documents for activities as authorized and described by Genentech policies and procedures.
- Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
- Interact directly with suppliers and internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigation, including but not limited to, identifying root cause, establishing corrective and preventive action plans, writing summaries, reviewing reference documents following company standards using designed IT tools.
- Provide final raw material disposition recommendations that may be affected by deviations or discrepancies.
- Support quality investigations for manufacturing deviations involving raw materials.
- Inform management of quality discrepancies and provide timely impact assessments of potentially affected products, materials, or processes.
- Develop and administer a system for tracking and trending of discrepancy investigations and associated Corrective and Preventive Actions (CAPA).
- Interact directly with suppliers and internal customers, and subject matter experts to evaluate vendor change notifications, develop evaluation plans to assess potential product/process impact regarding modifications to raw materials, equipment, processes, and facilities within standard lead times following company standard using appropriate IT tools.
- Lead and/or participate in supplier audits program.
- Includes, performing audits, writing finding letters and audit reports per established timelines, managing supplier certification program, improving supplier scorecard, initiate CAPAs to resolve discrepancy trends and seeking improvement opportunities to the current systems and processes.
What You Need to Bring to the Table:
- Working knowledge of cGMP, GLP, good clinical practices, FDA Guidelines and Points to Consider documents, applicable State and foreign regulations, and standards routinely used in the industry (ANSI, ISO, Federal Standards, etc.)
- Ability to interpret and relate Quality standards for implementation and review
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
- Strong interpersonal skills which include a professional demeanor when interacting with personnel at all levels within Roche worldwide operations, suppliers, contract manufacturers, regulatory agency representatives, etc.
- Flexibility in problem solving, providing direction and work hours to meet business objectives
- Requires excellent verbal and written communication skills, ability to influence others and work as part of a team.
- Some travel required
If This Sounds Like You, Apply Now!
Recruiter: Mary Nguyen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL; J2W; ENG
MONJOB
J2WPACNW
Ref:
SFSF: LS

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