The APAC Quality Manager maintains and optimizes the quality management system for the Asia Pacific region in support of commercial and logistics operations. This role will assess regulatory and business requirements and drive continuous improvement activities, ensuring the QMS fulfills both regulatory and customer requirements. In addition, the incumbent will also be responsible for the following:
- The complaint handling system for both regulated and non-regulated products based on the global complaint handling process.
- Represent the QMS as the Quality Management Representative per ISO requirements
- Serves as the primary point of contact for Notified Body audits and regulatory agency inspections
- Maintains and improves the site document management control, CAPA, internal audit, and supplier audit processes
- Supports the Quality Notification, Global Field Safety Notification & Ship Hold processes
- Organizes and conducts quality-related training to internal employees and distributors
- Maintains the Singapore controlled drug and poison licenses for the import and release of controlled drug products in Singapore.
- Supports Veterinary certificates or other government agency licenses activities for the Asia Pacific distribution center operation
- Manages the secondary assembly program at the Singapore Distribution Center
How You’ll Make an Impact:
- Ensures the QMS for Asia Pacific region is effective and aligned with the Complany Quality Policy and quality objectives, fulfills both regulatory and customer requirements
- Supports the commercial organization for the supplier audit program.
- Maintains controlled drug licenses and execute operation control on the release of controlled drug products.
- Support export documentation such as coordinating of the Veterinary certificate and poison licenses to support distribution center operation.
- Supports Australia, New Zealand and Korea import permit activities
- Assess and resolve gaps between regulations and the quality management system
- Maintains, optimizes, and improves current complaint handling system based on global complaint handling policy
- Responsible for post-market actions based on divisions’ CAPA plan and local regulation requirements. Support Quality Notification, Global Field Safety Notification & Ship Hold
- Be responsible for managing local SOPs according to Global SOPs. Maintain document control process
- Organize internal and external audits of the quality management system
What You Bring:
- Bachelor degree in Pharmacy. Professional pharmacist or intermediate certificate of clinical examination is preferred. Pharmacist registered with the Singapore Pharmacy Council
- At least 7 years' work experience in QA with 3 years management experience.
- Strong planning/organization skills
- Personnel management skills
- Good spoken and written English ability
- Strong ability to work effectively with diverse responsibilities
- Excellent interpersonal communication skills
- SAP ERP experience is a plus
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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