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 Position

Principle Roles & Responsibilities / Accountabilities

Technical 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 PTD

Local authorities such as SIFDC/NIFDC/XIFDC CPC

Local external sources such as supplier contract lab etc.

Planning production QA SHE and MSAT

Qualification and Experience

Education/Qualifications

Bachelors 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 deployment

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.