Lead Specialist QA Quality Systems, Quality - 1st Shift

1100 Mylan Pharmaceuticals Inc.; St. Albans (WV); On-site; USD 66,000 - 127,000; Full time

Job summary

Viatris is seeking a Manager, Quality Systems to lead investigations, CAPA actions, and cross-functional problem solving in a fast-paced GMP environment. The role involves reporting on APRs/MRs, site metrics, and leading improvement projects across the quality system. Strong communication, technical writing, and extensive cGMP experience are essential.

Exact compensation varies by skills and location. Viatris is an Equal Opportunity Employer committed to diversity and inclusion.

Qualifications

• BS degree with 10+ years of GMP experience
• Working knowledge of cGMP and change control
• Ability to perform statistical analysis and calculations
• Strong written and verbal communication

Responsibilities

• Lead complex/critical investigations, trends and CAPA actions, and prepare reports.
• Represent QA in deviation triage and containment decisions.
• Lead cross-functional problem solving in investigations.
• Compile/analyze investigation data for APRs, MR, site metrics and reports.
• Present findings to local and vertical leadership as required.
• Perform PQRs and oversight for potentially critical complaints.
• Lead trending assessments to identify corrective actions.
• Analyze investigation system reports to support APRs/PQRs and site metrics.
• Provide leadership for Site Quality System elements.
• Lead continuous improvement project teams and strategic initiatives.
• Develop strategies and manage task execution to completion.
• Approve laboratory investigations and incidents as authorized.
• Serve as Site Contact for Global Quality System initiatives.
• Mentor/train Quality Systems staff.

Skills

GMP experience

cGMP knowledge

Statistical analysis

Technical writing

Strong communication

Education

BS degree

Job description

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. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Every day, we rise to the challenge to make a difference and here’s how the Manager, Quality Systems role will make an impact:

Key responsibilities for this role include:

• Lead complex / critical investigations, trends, propose associated CAPA actions and prepare associated investigation reports.
• Represent QA in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact.
• Leads / facilitates cross functional structured problem solving in support of investigations.
• Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides.
• Present to local and vertical leadership as required.
• Performs PQRs.
• Provides oversight/assessment for Potentially Critical Complaints.
• Leads periodic and special cause trending assessments to determine corrective actions to address trends.
• Compiles/Analyzes investigation system related reports to support APRs/PQRs, Management Review, and Site Metrics.
• Provides leadership and oversight for assigned elements of the Site Quality System.
• Leads continuous improvement project teams.
• Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion.
• Approves laboratory investigations, incidents, and investigations as authorized.
• Serves as Site Contact/Back up for Global Initiatives related to improvement of Quality Systems.
• Provides mentorship and supports training/development of Quality Systems Specialist/Senior Specialist.
• Supports external Audits (ie: Corporate, Vendor, ISO etc.) and Health Authority Inspections.

The minimum qualifications for this role are:

• BS degree and 10+ years of relevant experience in a GMP environment, and comprehensive knowledge of Quality Systems and cGMP. A combination of experience and/or education will be taken into consideration. Must possess a working knowledge of cGMP and Quality Systems. Must understand the cGMP standards for change control and change implementation with basic understanding of regulatory expectations in relation to change management. Ability to add, subtract, multiply and divide. Statistical Analysis, Advanced Mathematical calculations. Must possess strong communication skills (written and verbal). Must have experience in technical writing.

Exact compensation may vary based on skills, experience, and location.

The salary range for this position is $66,000.00 - $127,000.00 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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.

We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life.

Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.