Head of Quality Control

Roche

  • Shanghai
  • Permanent
  • Full-time
  • 1 month ago
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionPrinciple Roles & Responsibilities / AccountabilitiesTechnical and Functional∙ Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures.∙ Direct QC Staff in the timely completion of testing (e.g. DP and FINP release and stability testing, raw materials, in process samples, utilities, direct materials, environmental monitoring, process and cleaning validation, and any other ad hoc samples such as complaint/AE sample testing, anti-counterfeit sample testing, IOEL/trace testing).∙ Ensure adequate resources and analytical capability. Provide QC staff with technical guidance on test methods and relevant procedures. Lead the team to build up analytical capability for biologics to further support local biologics business∙ Ensure timely generation and reporting of test results in support of manufacturing operations.∙ Ensure 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∙ Interact with the NIFDC and SIFDC for the sampling and testing related to in-country testing for Roche products.Leadership and People Management∙ Create an environment of strong team spirit, timely and effective communications, 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 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.Key Interfaces:PTQ Network QC, Other site QC leaders, PTR, PTDLocal authorities such as SIFDC/NIFDC/XIFDC, CPCLocal external sources such as supplier, contract lab, etc.Planning, production, QA, SHE and MSATQualification and ExperienceEducation/Qualifications∙ Bachelor’s Degree or above (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred)Leadership Competencies
  • Leads by example.
  • Strong leadership, teamwork and management skills.
  • Solid Talent and organizational development.
  • Fluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization
Job Required Competencies∙ 10 or more years’ work experience in the pharmaceutical or related industry∙ 6 or more years’ people management experience∙ 5 or more years’ relevant quality experience in the pharmaceutical industry (quality, analytical sciences, pharmaceutical development, manufacturing, or process development)∙ Expert knowledge in analytical areas 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∙ Possess good knowledge and expertise related to “Lean” and LPS deploymentWho we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.

Roche