TPM QA Associate Director

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.

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.

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:

• 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.
• 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 the TPM QA Associate Director you will manage the quality related activities at a number of Third-Party Manufacturers (TPMs), including Strategic TPMs (high volume, biosimilar, sterile products) based in the APAC region, producing products on behalf of Abbott and APO AG, to ensure safe, efficacious, and quality product supply in accordance with regulatory and business requirements. You will also manage APAC geographical activities assigned by management.

What You’ll Do

• Responsible for quality management of a number of Divisional TPMs.
• Accountable for quality oversight of TPMs, including: Supporting product registration and market launch activities. Leading TPM due diligence, onboarding processes, and establishing governance models. Supporting technology transfer activities as the Technology Transfer Quality SME.
• Manage all Quality System activities associated with the role.
• Develop and maintain Quality/Technical Agreements aligned with legal contracts and regulatory requirements.
• Responsible for managing highly complex TPMs.
• Manage high-impact exception events and CAPAs, ensuring appropriate assessment and documentation of impact to Abbott.
• Review and approve TPM Product Quality Reviews, ensuring accuracy, completeness, and management of actions to address identified trends.
• Review and approve complaints arising from TPM-manufactured products and follow up on complaint trend investigations for both non-medical and medical (adverse event) complaints.
• Manage all TPM changes with quality or regulatory impact, ensuring timely communication and implementation in line with regulatory requirements.
• Maintain a Quality Management Review program and Quality Performance Measurement process for TPMs to identify and address quality, operational, and organizational issues.
• Participate in QA cross-functional teams supporting TPMs, including Business Management Reviews where required.
• Visit TPM locations routinely to maintain expertise in products and manufacturing processes and build strong working relationships.
• Provide support to Abbott Senior Management through Significant Event and Management Review processes.
• Support TPM audit and inspection readiness activities.
• Manage direct reports.
• Act as the Single Point of Contact (SPoC) for the cross-regional TPM Quality Platform and contribute to cross-regional initiatives and objectives.
• Represent the TPM QA group in multi-functional divisional initiatives and projects, including continuous improvement and quality systems projects.
• Provide quality support for Technology Transfer Projects, ensuring compliance with all relevant quality requirements throughout the transfer process.
• Maintain successful Quality Metrics and support the team in achieving performance goals.
• Support New Product Introduction (NPI) processes and lead quality-related activities.

Requirements

• Bachelor’s degree or equivalent level of education in a relevant scientific discipline or other technical/scientific field, or industry experience with sufficient exposure to pharmaceutical or related industries.
• Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with a minimum of 15 years of experience in QA, QC, Operations, or Technical Support within a pharmaceutical environment.
• Manufacturing-related experience in one or more of the following areas: sterile, liquid, solid dosage forms, or APIs.
• Audit or supplier quality management experience within the pharmaceutical industry.
• Strong troubleshooting and issue resolution skills.
• Project management expertise.
• Demonstrated analytical and problem-solving capabilities involving people, resources, priorities, and facilities.
• Excellent written and verbal communication skills with internal and external stakeholders.
• Proven ability to work effectively across different cultures and overcome language and cultural barriers to achieve corporate, divisional, and local objectives.
• Experience using Quality Risk Management tools.
• Strong data analysis skills with the ability to develop strategies and action plans to resolve issues.
• Experience leading and managing teams.
• Strong understanding of quality systems, regulatory requirements, and compliance expectations in global pharmaceutical operations.
• Responsible for ensuring TPM compliance with Quality Agreements and applicable local and international regulations.
• Accountable for product quality assurance and compliance of commercialized products manufactured by assigned TPMs.
• Experience supervising direct reports and providing oversight to team members through regular reviews and guidance.

Apply Now

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

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

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