APAC Compliance, Commercial & Distribution QA Associate Director
Abbott · Singapore
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 APAC Compliance, Commercial & Distribution QA Associate Director, you will work with the APAC Region Commercial affiliates and sites to provide support and guidance regarding quality systems, compliance, commercial quality, distribution quality, audits, and regulatory requirements to ensure compliant, authentic, safe and efficacious products are supplied across the region.
What You’ll Do
- Provide Quality Systems leadership, tactical and strategic direction, and technical support to commercial affiliates in the APAC region.
- Maintain quality systems supporting regional supply chain and distribution activities, including GDP training, internal audit programs, document control, quality manuals, returns management, complaints and discrepancy investigations, and CAPA processes.
- Provide GDP support to affiliates, including audits, compliance support, event management, and exception handling.
- Select and approve Logistics/Transport Service Providers and Third-Party Warehouses for APAC Supply Chain operations.
- Collaborate closely with Supply Chain, Distribution, Master Data, QA Supplier Management, and Global Product Protection teams on projects including counterfeit prevention, regional warehouses, temperature monitoring, transport optimization, serialization, supply chain validation, and material listing approvals.
- Develop and manage the APAC Commercial Affiliate Quality Plan and provide training to ensure compliance with quality goals and standards.
- Support local market outsourcing activities and product launches through management of the First Lot Quality Review program.
• Implement and manage quality systems and training programs supporting CAPA, validation, complaint registration, physician sample handling, inspection reporting and tracking, and policy implementation. - Drive Management Review processes for commercial affiliates and advise senior management on compliance status and risk.
- Oversee Quality and Compliance activities across the APAC region to ensure products are supplied in accordance with regulatory and business requirements.
- Manage APAC regional Quality Systems and support global and strategic initiatives through implementation across the region.
- Lead regional GMP training management and represent APAC in corporate initiatives related to training, metrics, management reviews, document management systems, and quality management systems.
- Support GxP audits for APAC suppliers and affiliates and conduct due diligence audits for new business opportunities.
Requirements
- University degree for Life Sciences required.
- At least 15 years of combined experience in QA, Operations, or Technical Functions within a pharmaceutical environment.
- Working experience with commercial and distribution quality will be advantageous.
- 2 to 3 years’ experience managing complex projects or programs.
- Ability to use quality tools such as quality risk management, root cause analysis, benchmarking, gap analysis, pareto analysis, fish-bone diagrams, and process mapping for fact-based decision making.
- Project management and troubleshooting skills.
- Ability to communicate both written and orally to all levels of management and across different cultural backgrounds.
- Knowledge of international regulations and industry best practices for quality systems and compliance.
- Ability to identify problems and initiate corrective and preventative actions.
- Sound decision-making skills contributing to high levels of competence, confidence and credibility.
- Well-developed interpersonal, communication and negotiation skills.
- Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
- Change management experience.
- Experience in or working with regulatory organizations
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
N/AIn specific locations, the pay range may vary from the range posted.