Global TPM/Supplier QA Product Manager

The Opportunity

As Third Party Manufacturer and Technical Transfer QA Manager, you’ll 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 world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the TPM QA Manager, you’ll be responsible for:

• Providing QA support for assigned TPM’s 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

• Bachelor’s 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 and report 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 strategic Planning/ Thinking, decisive judgement, and Implementation 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.