Global TPMSupplier QA Product Manager

Third Party Manufacturer and Technical Transfer QA Manager- EMEA

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.

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:

• 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.

• 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.

The Opportunity

As Third Party Manufacturer and Technical Transfer QA Manager youll be responsible for TPM QA Management and Product Transfer and Technical Support for assigned TPMs.

This position works out of our in Netherland site in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.

As the TPM QA Manager youll be responsible for:

• Providing QA support for assigned TPMs to ensure that safe efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.

• Responsible for development of Quality Improvement Plan for TPMs remediations when required.

• Managing TPM activities while driving continuous improvement for TPMs.

• Responsible for Monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs

• Leading Quality Technical Agreements approval and periodic review

• Primary contact for communication of TPM Quality issues as needed.

• Responsible for maintaining TPM Approved Supplier Listing.

• Responsible for supporting Quality Compliance and improvement initiatives.

• Support new contract manufacturing site approvals must approve all new contract manufacturers for EPD commercial product within responsibility.

• QA Lead for investigations trends complaints corrective and preventive actions (CAPA) validation support product release issues PQR review and change control at TPM sites

• QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits new projects or initiatives.

• Analyzes data makes decisions or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.

• Recommends and implements changes to the system as the result of changing regulations and/or business needs.

• Coordinates across functional areas business units and/or geographies in order to achieve the impact goals.

As Product Technology Transfer QA Manager

Act as QA Lead for below quality activities during Product Technology Transfer

• Leading the initiation and implementation of Change Control / Stability and Change Impact Assessment.

• Test Method Transfer/Analytical Method Validation/Verification.

• Process Validation/Verification Program

• First lot quality review for release the validation batches for commercialization.

• Gather information from the Sending Unit in order to assemble a data package.

• Evaluate the information gathered and document findings with respect to product robustness.

• Participate to the process of creation approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.

• Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues

• Involve in support the quality aspects of the Product Portfolio Expansion Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.

• Ensure that projects and technical activities associated with Drug Substances Drug Products Intermediates and non-pharma products (food supplement medical device cosmetics) are carried out without business interruptions and according to legal and Abbott Quality Regulatory and business requirements.

• Liaison between sites QA commercial affiliates MS&T (Manufacturing Science and Technology) Operation Regulatory and other groups as necessary.

• Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues risk assessment target cost initiatives and other continues improvement initiatives.

Required Qualifications

• Bachelors degree in science pharmacy / pharmaceutical technology biotechnology / microbiology or equivalent level of education at a relevant scientific discipline.

• Minimum 10 years of experience in the pharmaceutical manufacturing field (Quality production technical support etc.)

• Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations

• Knowledge of international and local quality system and compliance legislations and standards

• GMP/GLP/GCP background related to medicinal products medical device food supplement Biotechnological Biosimilars and Biologics

• Good communication andreport writing skills in English (mandatory).

• Strong leadership skills in bringing the best out of people managing work teams and fostering teamwork within the department.

• Strong strategicPlanning/ Thinking decisive judgement andImplementation skills.

• Flexible for Travel: 30 %

Preferred Qualifications

• Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid liquid injectable and biosimilar products.

• High capabilities in time management negotiation skills multi-tasking communication skills and Microsoft offices.

• Other qualifications/certifications: IRCA Lead Auditor Certification Auditor Certification Training Complaint Certification GMP-GDP Training. Highly skilled on cGMP requirements team management and Quality Assurance / Quality Control manager for solid and injectable products.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

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