This position is responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of generic pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and X-GEN's Quality Management System. The Manager, External Manufacturing, Quality Assurance, will act as the lead quality point of contact for assigned Projects.

Specific job responsibilities include:

Supports X-GEN's Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.

Independently manage and provide quality oversite as well as lead daily quality related interaction and commercial production execution and/or product transfers with third parties and cross functional teams to assure:

  1. Quality and compliance related matters meet appropriate GMP and regulatory requirements.

  2. Product is safe, pure and effective for distribution by direct review and inspection of the finished goods and documentation.

  3. All documentation for release is present, accurate and within established ranges and specifications.

  4. Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and /or contractual agreements.

  5. Representation of the department and X-Gen on cross-functional project teams and external business partner meetings.

  6. Compliance with cGMP's, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external partners.

  7. High performance of third party contract manufacturers by implementation of quality metrics and scorecard.

Assures timely launch of new products by:

  • Serving as the Quality lead for technical transfer activities at external manufacturing partners.

  • Reviewing ANDA filings for identification of deficiencies and compliance to the requirements.

  • Supporting manufacturing activities related to regulatory filings (i.e. on-site presence for engineering, validation, registration batch manufacturing, timely review and approval of documents, etc.)

  • Participation in and advisement of responses related to filing deficiencies.

  • Supports X-GEN's Operations related to commercial product distribution by:

  • Approving and releasing commercial product.

  • Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints.

  • Certifying that all incidents, complaints, and investigations are properly documented.

  • Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action.

  • Investigating and determining the need for field alerts or recalls of company products manufactured by third party contract manufacturers.

  • Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation.

  • Perform on-site visits during manufacturing/packaging of X-GEN products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and X-GEN's requirements.

  • Participating in Agency and X-GEN inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites.

  • Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary.

  • Driving quality compliance and performance metrics with external manufacturing partners and reporting metrics on a routine basis.

  • Compliance with cGMP's, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external.

  • Performs other related duties as assigned or directed.

    Education: Bachelor Degree in Science-Related (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering) 5-8 years of work experience in Quality Assurance within the pharmaceutical industry or 3-5 years of experience working with pharmaceutical Contract Manufacturing Organizations (CMOs) and business.

    Training (licenses, programs, or certificates): ASQ Certified Auditor (desirable, not required)


    • Proficient reading, writing, grammar, and mathematics skills.

    • Proficient interpersonal relations and communication skills, including use of English language.

    • Moderate computer skills including Microsoft Office, Go To Meeting.

    • Travel: 50% domestic and international travel required.

    Other Skills

    Quality Assurance and Quality Control; cGMP; Contract Manufacturing (CMO); domestic and foreign regulations governing GMP plant operations and Relationship Management. Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines


    Minimum: 3 years

    Proficient: 10 years


    Operate standard office equipment.

    Physical Requirements:

    Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds.

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    Qa Manager, External Manufacturing Located At Ny, Horseheads - Job Post By: X-gen Pharmaceuticals

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