QA Manager Global Third Party Manufacturing & Global Supplier Quality

Job description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Opportunity

The QA Manager Global TPM & Supplier will manage the quality related activities at a number of Third-Party Manufacturer’s (TPM’s) and/or suppliers producing product on behalf of Abbott and APO AG, to ensure safe, efficacious and quality biologics (biosimilars) and nonbiologics drug product can be supplied in accordance to regulatory and business requirements.

Core Job Responsibilities

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Manage TPM’s and/or Suppliers as assigned from a Quality perspective an, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements

· 
Manage all Quality System activities associated with the role, including:

· 
Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.

· 
Management of high impact exception events and CAPA ensuring events are appropriately assessed for impact to Abbott and documented.

· 
Review and approval of TPM Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.

· 
Review and approval of complaints arising from TPM/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.

· 
Management of all changes at TPMs/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.

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Maintain a Quality Management Review program and Quality Performance Measurement for TPMs / Suppliers, that identify and address quality, operational, and organizational issues.

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Participate on QA cross-functional teams to support TPMs, including active participation in Business Management Reviews or Workstreams, as necessary.

· 
Visit TPMs &/or supplier locations routinely to build and maintain expertise with products and manufacturing processes building a close working relation with the TPM &/or supplier

· 
Provide support to Abbott management through the Significant Event and Management Review process to ensure relevant information is provided for events impacting assigned TPM/Suppliers.

Position Accountability / Scope

This position is responsible and accountable for

· 
Responsible for ensuring that TPM’s &/or suppliers maintain compliance with the Quality Agreements and local and International regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy and quality are maintained.

Minimum Education

· 
Bachelor Degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries

Minimum Experience/ Knowledge Required

· 
Total combined years: 8+ in  QA, Operations, Pharmaceutical engineering, with minimum of 3 + Biopharmaceutical experience preferred.

· 
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations. 

· 
Excellent knowledge of GMP as described in EMEA/PICs regulations for biopharmaceutical sterile manufacture. 

· 
Knowledge of international and local quality system and compliance legislations and standards including but not limited to Biopharma, pharma and medical devices.

· 
Leadership experience

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

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Career development with an international company where you can grow the career you dream of

· 
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

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A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

How to apply?

Please apply by sending your CV and motivation letter to this website, or directly to recruitment.netherlands@abbott.com, attention: Niels Dijkstra. Applications will be assessed on a regular basis.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Netherlands > Weesp : WHS 02

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable