Quality Compliance Senior Specialist/Associate Manager

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
(Major functions of the position)                                

Regulatory Compliance

• Lead the implementation of regulation related to SRPL GMP/MAH.
• Take part in external communication with HAs as needed; maintain Drug Manufacturing License of SRPL with close collaboration with SMEs, as applicable.
• File the company facility/key organization change to local HA as per regulation in a timely manner to ensure the compliance of activities.
• Responsible for the communication with HAs with the purpose of moderate the progress as per expected by the corporate.
• As appropriate, lead/support the documentation preparation and submission.
• As appropriate, lead/support the completion of the HAs’ requests to ensure timely and effective responding mechanism to HAs.

Inspection and Audit Management

• Hosting and management of HA inspections, internal and external audits and paper-based inspections (HAs inspections, Corporates/Enabling Compliance team audits).
• Notify all relevant inspection information before, during and after the inspections to all relevant parties in a timely manner and ensure inspection readiness.
• Lead the activity to define, collect and check pre-requests and inspection requests as per timeline with close collaboration with SMEs.
• Hosting and lead the support of external inspections ensure all the readiness activities are completed and inspection compliance risks are escalated and communicated within appropriate management levels in time.
• Responsible for the response process and follow up on the mitigation activities, including coordination and interface with Global Functions and/or network sites as required. Ensure the responses are submitted within the defined timelines, track inspection commitments and ensure in time escalation.

Site and CMO Self-inspection

• Lead the establishment and execution of the E2E self-inspection program to ensure the program drives continuous improvement of the site and CMO’s systems, processes and quality compliance performance.
• Work closely with all internal auditors to continuously optimize the self-inspection process, to support the self-inspection mechanism being built up and implemented in site and CMO to ensure the self-inspection plan is sound established, fully executed and potential compliance risks be identified and mitigated.
• Maintain and consciously improve internal auditor pool and qualification.

MAH annual report

• Lead MAH annual report related activities for Roche Shanghai.
• Organize and coordinate other departments to collect data information for MAH annual report, and submit MAH annual report in NMPA annual report system after final review and approval,.
• Continuously improve annual report process

Others

• Oversight quality compliance status for SRPL GMP/MAH related including interface with global functions, leveraging self-inspection program, quality metric review, etc.
• Organize credit rating assessment for Roche Shanghai
• Coordinating to handle HA Consultation, Survey, and Sampling activities.
• Supporting other businesses from Quality System and Compliance team if needs (e.g. Change Control, PQS, etc.)

Qualification and Experience

Education/Qualifications

• Bachelor’s Degree required (Pharmacy, Science, Biology, Biochemistry or bio engineering is preferred); Graduate or higher-level Degree is preferred.
• 5 or more years’ Quality Unit experience in the pharmaceutical industry.

Leadership Competencies

• Models Integrity
• Focus on value and customer
• Align for success
• Deliver results
• Learn for the future

Job Required Competencies

• Good knowledge of Quality System and Compliance principles, practices and standards for the pharmaceutical industry.
• Good knowledge of cGMP relevant to the pharmaceutical industry, knowledge of the local and international GMP regulations.
• Good understanding with audit or inspection management.
• Manage oneself/demonstrate leadership within own role.
• Well communication skill and good accountability of problem solving.
• Good at English, listening, speaking, reading and writing.

Who we are

A 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.