About this opportunity
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
Engineering Project Support and Operation Readiness:
● Collaborate with cross-functional teams to implement GMP-related systems, processes, and workflows for the production department.
● Develop and implement GMP training programs tailored to production staff, aligned with corporate quality policies and regulatory requirements.
● Establish the deviation management and CAPA processes in manufacturing for handling non- conformances effectively and ensuring timely resolutions.
● Implement a robust change control process, ensuring GMP compliance and proper documentation of changes in the production environment.
● Participate in the preparation for facility qualification audits and regulatory inspections, ensuring that all systems and practices meet GMP standards.
● Lead consumable materials/service introduction and track the status to ensure to meet the manufacturing requirement.
● Support the development of GMP documentation including SOPs, validation protocols, and project-specific documentation for compliance.
● Perform other duties as assigned.
Routine Operation:
● Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
● Serve as the primary interface between the production department and QA/Compliance teams for GMP-related matters.
● Manage ongoing GMP training programs, ensuring production personnel are regularly updated on GMP and compliance requirements.
● Oversee the timely identification, investigation, and resolution of deviations, ensuring proper execution of CAPAs to avoid recurrence.
● Evaluate and coordinate changes within the production department, ensuring proper implementation and documentation in line with regulatory requirements.
● Act as the production department’s primary liaison during internal and external audits, ensuring inspection readiness and addressing observations.
● Monitor GMP compliance in daily operations, identifying gaps and implementing corrective actions.
● Proactively identify areas for improvement in GMP operations, driving initiatives to enhance quality and productivity while maintaining compliance.
● Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
● Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
● 5 or more years’ operation experience in GMP compliance roles in the injection pharmaceutical industry, MNC Bio-pharma preferred.
● Experienced in strategic projects of facility including design, commissioning & qualification is preferred.
● Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
● Hands-on experience in deviation handling, CAPA management, change control, and audit preparation is required.
● Familiarity with compliance tools and systems for managing training, deviations, and CAPAs.
● Fluent communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
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.
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 3753 comparable Manufacturing & CMC roles across 173 biopharma companies.
Salary context
921 of 3753 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
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Seniority mix
1670 of 3753 peers have a known seniority level
Therapeutic area mix
24 of 3753 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.