Quality Compliance Manager

Job Title: Quality Compliance Manager
Location: Woodlands, Singapore

**About the role**:
This position is responsible for inspection and audit management, site quality compliance governance and product quality and compliance communication to achieve the site objectives for Takeda Singapore.

**How you will contribute**:
Inspection and Audit Management
- Inspection and Audit Management
- Lead the Quality Compliance team to host and manage regulatory inspection and communications.
- Lead the Quality Compliance team to ensure the site is inspection ready at all times.
- Lead the site to execute the respective inspection readiness activities.
- Lead the Quality Compliance team to conduct gap analyses of internal/external inspections and CAPAs.
- Own, maintain and update Site Master File (SMF).
- Maintain GMP certificates and licensure documentation.
- Act as SME in quality and compliance.
- Identify major compliance issues in a timely manner and present to the management. Develop tactical and/or strategic action plan to mitigate the identified compliance risks.
- Prepare and report audit & compliance metrics to site management.
- Establish partnership with applicable site functions to meet compliance objectives.
- Lead continuous improvement for Quality projects and CAPA, in collaboration with other site functions, to support QMS transformation programs within scope of Quality Compliance.
- Lead and manage the self-inspection program.

Site Quality Compliance Governance
- Lead and ensure site quality compliance governance, including site KPIs and metrics and Quality Council is executed according to regulatory, corporate and division requirement.
- Provide quality oversight for site Quality Risk Management

Product Quality and Compliance communications
- Lead the Quality Compliance team to report product quality issues to health authorities in collaboration with PQIM as per quality incident management process.
- Lead the Quality Compliance team to coordinate site notification to management.

Product Complaints program management
- Lead the Quality Compliance team to coordinate site product complaints to ensure timely investigation and report for customer complaints and product recall, in collaboration with PQIM as per corporate requirement.

Leadership
- Manage, coach and develop Quality Compliance team and contribute to the growth of the team members.
- Drive and define strategies, priorities and compliance standards across the areas of accountability.
- Liaise with Quality Compliance counterpart from other sites for information learning and sharing and alignment for best practices.
- Ensure succession planning by identifying high potential employee to be the successor for the Quality Compliance Manager to ensure business continuity.
- Build strong relationship with all departments to ensure open communications and acceptance.

Other responsibilities
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.

**What you bring to Takeda**:

- University degree in Biotechnology, Chemistry, Pharmacy, Science, Engineering or equivalent.
- At least 8 years of experience in Pharmaceutical or related manufacturing environment.
- Demonstrated ability to collaborate with cross functions or cross sites to achieve objective.
- An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.
- Ability to create and mediate common understanding and communicate expectations on compliance.
- Presentation skills for audit, training and Senior Management.
- Substantial knowledge in regulatory requirements, such as Eudralex, 21CFR, ICH, etc.
- Able to logically solve problems in order to find timely solutions.
- Audit skill and audit management experience.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:

- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veter