Technical Manager, Quality Job

SENIOR TECHNICAL MANAGER, QUALITY needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE:

The Senior Technical Manager position will provide Quality oversight for products and drug delivery systems manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Systems Regulations, Medical Device Directives and standards. The position will be a key member of Drug Product/Device CMO governance teams and will serve as the Quality single point of contact for selected CMOs.

Top Skills Should You Possess:
- Quality
- Combination products
- Six Sigma

What You'll Be Doing:
- Serve as the Quality Single Point of Contact for selected aseptic fill/finish CMOs to assess quality and compliance with the regulations. Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Develop, negotiate and maintain Quality Agreements with CMOs and establish CMO Quality goals/metrics and monitor progress.
- Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.
- Support the release of finished clinical and commercial combination product including batch record review, resolution of investigations and quality issues, and assessment of change controls. Represent department at Quality Review Board and Change Review Board meetings.
- Support regulatory filings for products manufactured at CMOs. Participate in regulatory inspections and compliance audits and collaborating with CMO's to ensure on-time closure of associated CAPAs.
- Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology. Perform any other tasks as requested by Management to support Quality oversight activities.
- Collaborate on and/or author department policies and procedures and act as a trainer/subject matter expert (SME) on Quality systems, standards or processes as required.

What You Need to Bring to the Table:
- BS degree in Life Sciences discipline, Graduate degree preferred and at least eight years of experience in the pharmaceutical, biopharmaceutical, device injection or diagnostics.
- Hands on expertise in aseptic manufacturing preferred
- Demonstrated capability of applying risk management concepts and tools preferred
- Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred.
- Sound knowledge of cGMPs and relevant international regulatory requirements.
- Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.
- Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma/DMAIC is preferred
- Travel required is approximately 10 - 20%

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.

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