Quality Technical Manager Job

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

TOP SKILLS SHOULD YOU POSSESS:

- Global device regulations
- cGMP
- Guidance documents

WHAT YOU'LL BE DOING:

- The successful candidate will support the establishment of device related global regulation, harmonized standards and guidance documents within the Global Pharmaceutical Quality System (PQS).
- Major responsibilities will include the review of the Global Pharmaceutical Quality System (PQS) with respect to global regulation, harmonized standards and guidance documents, the identification of detailed gap assessments and specific recommendations (red-lined documents) to address those gaps per the aligned priorities outlined in the PQS Device Strategy.
- He/she will work with the PQS Device Workstream team members, authors and global coordinators of the various documents to review the recommendations and develop an initial agreement on the proposed changes to impacted PQS documents.
- The successful candidate will work with the authoring community assigned by the PQS Business Management Team (PQS BMT) to obtain input to the document from across the network, and obtain alignment on controversial points.
- He/she will work with the author and global coordinator to route the document through the review and approval process.
- The successful candidate will also support the PQS BMT in the inclusion of device regulation references into the tool being developed to aid maintenance of the PQS to current requirements.
- He/she will work with the global coordinator and support personnel to track implementation of the changes, including closure of Parent CAPAs related to implementation of revised or new documents, development and close-out of any Pharmaceutical Technical Quality System (PTQS) department specific child CAPAs associated with the changes or new document and associated change records.
- Key deliverables will include: 1) detailed trace matrixes to key regulation, harmonized standards and guidance documents, with details on whether the requirement is relevant to a specific PQS document, and if relevant exactly where in the document the requirement has been addressed, 2) red-lined or new PQS documents, 3) the document request form for review by the PQS BMT, 4) updated and/or new training materials, 5) approved and effective documents, 6) change documentation, including parent CAPAs, impact assessments and change records.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor of Science, preferably in an engineering or science related field.
- Candidate will have a 10-15 years of experience in the Medical Device industry, with a preference for this experience to include a minimum of five to seven (5-7) years in quality and/or quality systems and experience in the Pharmaceutical industry.
- Extensive knowledge of global device regulations, standards, guidance documents and cGMPs is required.
- The candidate must be highly organized and detail oriented. A proven track record of working effectively in a Matrix organization with a highly cross-functional and collaborative environment is very desirable.
- Excellent verbal and written communication skills are required. Evidence of proof-reading skills and the ability to detect inconsistencies within and across multiple documents is desired.

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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