Sr Splst/Asso. Manager, CMO Quality Management

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

The Opprtunities:

Principle Roles & Responsibilities / Accountabilities

Quality Oversight

• Define and deploy the schedule for Quality Oversight in CMO site

• The scope of quality oversight should cover all the CMO production related areas and quality activities including warehouse, laboratory, production plants, facility/utility/equipment, etc. and the batch record

review, etc.

• Drive the correction and prevention for the observation from quality oversight

• Regular analysis and report for the observation from quality oversight

Oversee CMO product batch release process

• Provide QA Support to production scheduling, change control and validation.

• Ensure on-time batch disposition per Roche SDP (Supply Delivery Performance).

• Ensure products are not sold or supplied before QP/AP release, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant.

Provide QA oversight on direct materials/API management.

• Ensure direct material/API release on-time

• Oversee material quality including Specification, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc.

• Support local supplier quality management including audit, Quality Agreement etc.

Coordination and handling for CMO quality related issue

• Involve and support the CMO products related unplanned event.

• Involve and support planned event.

• Involve and support the investigation of CMO related OOS/OOT

• Lead the investigation of CMO product related complaints

Other quality related activities

• Draft and review the CMO product APQR.

• Involve and support the inspection by HA and Roche Global inspection on CMO sites.

• Coordinate and involve in the Self-inspection on CMO sites by SRPL.

• Support the job of maintaining the business needed licenses.

• Maintain the CMO quality agreements.

• Qualify the CMO QA for batch record review.

• Involve quality related projects

• As the quality bridge between Roche and CMO sites, ensure the quality information exchange timely.

Lead and promote the continual improvement of quality management system in CMO site

• By deploy the QSMR, QCS and QRM

• By communication of the specific technical topics

Complete other tasks assigned by senior leaders

Who you are:

Education/Qualifications

• Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)

• Graduate or higher-level Degree is preferred.

Job Required Competencies

● Experience (may vary depending on site size/scope)

✓ 5 or more years’ work experience in the pharmaceutical or related industry

✓ 3 or more years’ experience in a commercially licensed GMP facility

✓ Experience on solid and/or aseptic processing is preferred

● Knowledge/Skills/Competencies

✓ Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry.

✓ Expert knowledge of cGMP relevant to the pharmaceutical industry

✓ Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.

✓ Project management skills

✓ Demonstrate excellent verbal and written communication skills in English

✓ Focus on value and customer

✓ Learn for the future

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.

Roche is an Equal Opportunity Employer.