changing lives.
The APAC Regulatory and Quality Assurance Department has a position in APAC for a Quality Assurance (QA) Manager to support the region Quality Management System. This role will lead, establish, maintain, coordinate and support APAC Quality Assurance in meeting Align’s Quality goals via an effective Quality Management System to ensure that business processes across APAC are in full compliance with medical device regulations within the region and Align’s internal requirements.
The position also assesses the changes to applicable laws and legislations that could affect the organization in APAC and provides guidance to the APAC function on matters relating to quality. This position is based in Align’s Singapore office and reports directly to the Director, Regulatory Affairs and Quality Assurance, APAC, in the APAC corporate HQs located in Singapore.
In this role, you will…
- Responsible for the implementation and maintenance of the Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures which ties to the “One Align” and “Quality First” principles to establish a Global Harmonized Quality standard for Align commercial and manufacturing sites across APAC.
- Responsible as APAC QMS Harmonization lead to interface with Global/Site QA for the region on matters relating to Global QMS Harmonization.
- Responsible for APAC Align Sites and their 3rd Party Quality Audit Program; conduct risk assessment to establish the annual APAC Internal Quality Audit Schedule, implement the audit program, create audit plan and lead these internal and external audits to ensure sites’ audit readiness by External Regulatory bodies and Corporate . Drive closure to audit findings including investigation, implementation, and effectiveness checks.
- Responsible for evaluating region/local sites Change Controls/CAPAs, in collaboration with local RAQA, to determine if issues impact product safety, product labeling, regulatory submissions or requires further actions (e.g., recall) or reporting and coordinate with Global RAQA as needed.
- Assume the MR role for APAC sites, as applicable.
- Monitor and assess changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with APAC process owners to define improvements.
- Responsible for training of APAC sites on topics relating to QMS, Global QMS Harmonization, Internal Audits, CAPA, Change Management, etc.
- Supports new business expansion in APAC, ensuring its quality compliance.
- Assists with all department projects as required.
In this role, you’ll need …
- Over 8 years in Quality Assurance role at a healthcare/medical device company.
- Fluent in English writing, reading and communication skills to interact with global and regional teams including external regulatory requirements
- In depth knowledge of Quality System regulations – GMP, GDP, ISO 13485, etc., with its implementation experience and lead auditor skills.
- In depth CAPA and Change Management experiences.
- Experience in performing processes mapping, workflows and writing Quality procedures .
- Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
- A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
- Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
- Ability to work independently, and handle both small and large matters with equal effectiveness and enthusiasm. Execute project/program tasks with general supervision and little guidance.
- Ability to do research and come up with comprehensive and compliant solutions for quality challenges.
- Ability to work cross-functionally with multiple projects, solving problems and communicating issues.
- Must be able to thrive in a fast-paced environment with evolving regulatory landscape, be willing to adapt to change, as well as being capable of driving change.
- Bachelor Degree in Science or Engineering preferred.
