GxP Supplier Quality Manager
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
Technical Job Responsibilities
● Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select,
Implement, Manage and Decommission), including but not limited to: process or method validations,
Roche audits, Health Authority inspections, complex investigations, product complaints, and
regulatory submissions, as assigned.
● Develop, negotiate and maintain Quality Agreements and Product Specific Requirements (as
appropriate) with GxP suppliers, as well as with Partners, Collaborators and External Sponsors as
applicable, and ensure compliance with agreements.
● Collaborate with GxP suppliers to address any gaps in audit responsiveness, CAPA implementation,
deviation reporting and management, complaint management, investigation closure, and change
implementation with regards to quality and timeliness with the supplier; and escalate as appropriate.
● As applicable, manage all required quality activities to support Make Assess Release (MAR) of
Roche products including approval of master process documentation, batch documentation review,
resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality
performance.
● As applicable, release, reject or quarantine products (drug substance or API, bulk drug
product, and semi-finished and finished products) and medical devices produced within the area of
responsibility per applicable Roche requirements, cGMP and the schedule. Support RP and QP
Declaration and Certification requirements as applicable.
● As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the
Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory
dossier, including stability testing programs. Also includes quality oversight for direct material
changes, certifications, supplier specifications and internal release specifications, and other
documentation.
● As applicable, develop and maintain quality risk management plans; utilize risk management tools to
identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of
compliance.
● As applicable, manage or lead quality deliverables supporting technical transfers for manufacturing,
testing, packaging and product launches at external sites
● As applicable, engage in supplier improvement initiatives to solve complex manufacturing or quality
problems.
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 Quality role in our database, not just this employer's listings.
We currently track 164 comparable Manager Quality roles across 51 biopharma companies.
Salary context
44 of 164 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 164 comparable roles
+ 19 more countries
Seniority mix
164 of 164 peers have a known seniority level
Therapeutic area mix
0 of 164 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
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.