Head of Quality Compliance and Systems

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Job Description

Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Title: Head of Quality Compliance & Systems

Location: Woodlands, Singapore

About the role:

This position is required to lead the Quality Compliance & Systems (QC&S) Department which includes Quality Compliance and Quality Systems. The role is responsible for ensuring compliance with all applicable provisions of Takeda Quality Management System (QMS), and the regulations and standards applicable to Singapore site operations. This role involves leading gap analysis, implementing QMS procedures across the site, and managing compliance. The Head of QC&S interfaces with regulators during inspections, oversees Quality Council meetings, and manages the Product Complaint Management process. Additionally, this role is responsible for Quality Validation and change review board (CRB) oversight, product quality review (PQR), driving Quality Risk Management (QRM), Data Integrity, supplier quality management and fostering a strong compliance culture at the site.

How you will contribute:

Operations & Technical Guidance

• Lead gap analysis and implement Quality Management System procedures across all departments

• Lead and interface with regulators during inspections, acting as QMS system SME and owner.

• Assure the appropriate execution of Quality Council meetings, including summaries of the data presented, conclusions, meeting minutes, and tracking action items to closure

• Provide guidance to the team for the execution of annual Product Quality Reviews, periodic quality trend reviews needed to demonstrate the Quality performance of the site.

• Review site-impacting regulatory and customer responses, working with SMEs to assure timeliness and accuracy.

• Manage the Product Complaint Management process and coordinate escalations for review associated with product hold, BPDR, Field Corrective Action decision and related regulatory notifications.

• Work closely with Quality Incident Management team to ensure that incidents are escalated in a time manner as well as closed according to Takeda QMS requirements.

• Oversee Quality Validation activities and milestones.

• Oversee change review board and change control QMS.

• Identify, manage, and lead QMS continuous improvement projects to achieve quality, efficiency, and cost improvements.

• Drive and support Quality Risk management, Data Integrity, Supplier Quality Management and a strong quality compliance culture at the site.

• Serve as sponsor and leader for key departmental and site projects

• Develop, manage and adhere to QC&S budget planning, forecast and execution, including OpEx, Capex, resource planning and continuous improvement projects.

• Assure the implementation and alignment of operations with GQ/GMS/DD&T digital initiatives.

• Adhering to domestic and international GMP regulations, cGMP, company policies, Takeda leadership behaviors, and conducting performance management.

• Actively champion and role model Takeda Quality Culture of continuous improvement, learning organization principles and innovation as well as adherence to the principles and values of Takeda-ism.

• Identify, investigate, and resolve quality issues and gaps through continuous improvement and ensure site compliance with current regulations, market trend and Takeda QMS requirements.

• Sets direction for the QC&S team whilst proactively shapes relevant policies and influences organizational goals.

Leadership

• Drive and define strategies, priorities and compliance standards across the areas of accountability.

• Liaise with quality counterpart from other Takeda sites for information learning & sharing and alignment of best practices.

• Manage, coach and develop QC&S team.

• Lead talent development and succession planning by identifying and grooming high potential talents for succession planning to ensure business continuity.

• Build strong relationships with global stakeholders and cross-functional site departments to ensure open communications and acceptance.

• Represent the Site Quality Head as needed and when it is requested.

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:

Education and Experience Requirements

• At least a degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, engineering or a related discipline. Additional certification and training such as auditor training or QP training will be advantageous.

• A minimum experience of 10 years, with 5 years of supervisory position, in pharmaceutical or biotechnology quality functions, GMP compliance, operations or validation, ideally in a multinational company.

• Substantial knowledge of regulatory requirements, such as FDA 21CFR, EU Eudralex, ICH Guidelines, PIC/S GMP Guide, EU GMP Annex 1, etc.

• General knowledge of biologics manufacturing processes, laboratory operations, clean utilities and product disposition.

Key Skills and Competencies

• Good leadership skills and ability to effectively communicate up, down and across the organization

• Good leadership skills and demonstrated success in positively influencing stakeholders

• Demonstrated ability to collaborate cross-functionally, across sites and above sites to achieve objectives.

• Experience in hosting and conducting HA inspections, including FDA, EMA, HSA or equivalent

• Proven experience in hosting and leading inspection preparation and managing inspection readiness program.

• An ability to interact and communicate with different personalities in an effective and diplomatic manner

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.

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