- Salary: Undisclosed
- Location: Singapore - West
- Work Type: Permanent / Full Time
- Min. Education Level: Degree
- Field of Study: Not Applicable
- Years of Experience: 15
- Skills: Quality Management
- Oversee the development and implementation of Quality Control strategy and activities for assigned Site. Oversees generation, review and compliance of locally developed and approved procedures with company-wide quality policies and standards.
- Direct staff and operations within Quality Control groups in accordance with cGMP regulations and the Roche/ Genetech’s standards.
- Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control for the site.
- Monitor and ensure the performance and delivery of results for the Quality Control testing laboratories.
- Provide leadership and guidance to immediate staff performing Quality Control activities. QC activities include sampling, sample management, testing of DS, DP, and finished goods (release and stability) as well as raw materials, in-process, devices, direct materials, utilities and environmental monitoring of classified areas as well as retention sample management as defined by site requirements.
Key Responsibilities/ Tasks
Leadership and People Management
- Create an environment of strong team spirit, timely and effective communication, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
- As a leader within the Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision making.
- Accountable for overall budget and financial performance of the Quality Control function.
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
- Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
Technical and Functional
- Establish, modify, implement and enforce Quality Control policies, procedure, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/ Genetech standards, policies, plans, objectives and procedures. (e.g. in Germany: Responsible as “Leitung der Qualitätskontrolle, LQK”)
- Direct QC Staff in the timely completion of testing (e.g. DS, DP and FINP release and stability testing, raw materials, in process samples, utilities, direct materials, medical devices, environmental monitoring, process and cleaning validation).
- Provide QC staff with technical guidance on test methods and relevant procedures.
- Ensure timely generation and reporting of test results in support of manufacturing operations (e.g. hold testing).
- Ensure timely and appropriate calibration and maintenance of laboratory equipment and systems.
- Ensure support of manufacturing operations through troubleshooting, transfer activities and other product lifecycle testing.
- Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
- Ensure system, computer, change control, and analytical data is reviewed, evaluated and approved against established criteria.
- Ensure data is generated, documented and reported following cGMP procedures.
- Direct the review and approval of all applicable Quality Control documents and ensure documents are updated.
- Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods.
- Lead Analytical transfers and local analytical method verifications as required by sites.
- Direct QC Staff in the timely resolution of issues, including discrepancies, investigations, and implementation of CAPA (corrective actions preventive actions).
- Escalate any potential quality issues revealed during QC testing or processing of products (e.g. QRB), especially quality or regulatory issues with the potential to affect product quality or regulatory compliance.
- Support regulatory inspections and partner audits, approvals of protocols and reports of third party QC laboratories.
- Liaise with regulatory agencies and external sources regarding issues affecting product quality as QC SME.
- Bachelor’s Degree required (Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline is preferred); additional requirements may be specified by site and local needs.
- Graduate of higher-level Degree is preferred
- 10 or more years’ work experience in the pharmaceutical or related industry
- • 6 or more years’ people management experience
- • 4 or more years’ relevant quality experience in the pharmaceutical industry (Quality, Analytical Sciences, Pharmaceutical Development, Manufacturing, or Process Development)
- Expert knowledge in assay transfer and regulatory submissions
- Expert knowledge of cGMP relevant to the pharmaceutical industry; including knowledge of laboratory safety procedures
- Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
- Possesses strong verbal and written communication skills and the ability to influence at all levels
- Builds trustful and effective relationships
- Able to think strategically and translate strategies into actionable plans
- Takes responsibility, drives results, and achieves expected outcomes