Site Self Inspection Lead, Quality Assurance - 1st Shift
Notify me about similar jobsAbout this opportunity
Mylan Technologies, Inc.
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Every day, we rise to the challenge to make a difference and here’s how the Site Self Inspection Lead will make an impact:
Key responsibilities for this role include:
Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility.
Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness.
Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.
Responsible for Site Audit Module and associated processes and procedures.
Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.
Participate in Global Operations Audits of Viatris facilities.
Perform external audits of third party suppliers as aligned with site and GOA requirements.
Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.
Support any of the site quality culture initiatives.
The minimum qualifications for this role are:
Must possess extensive knowledge and understanding of pharmaceutical cGMP and global government regulations, including Viatris policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001 (as applicable to the site).
Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP’s to support evaluation and enhancement to site systems and processes.
Minimum of a Bachelor's degree in Science, Engineering, or related technical discipline with at least 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance. However, a combination of experience and/or education will be taken into consideration.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
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 1065 comparable Quality roles across 134 biopharma companies.
Salary context
210 of 1065 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
Top locations among the 1065 comparable roles
+ 43 more countries
Seniority mix
524 of 1065 peers have a known seniority level
Therapeutic area mix
2 of 1065 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
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.