Lead Specialist QA Quality Systems

Regulatory Jobs; St. Albans (VT); On-site; USD 66,000 - 127,000; Full time

Job summary

Mylan Technologies, Inc. is seeking an experienced QA leader to drive complex investigations, manage CAPA actions, and ensure excellence in a GMP environment.

The role emphasizes QA triage of deviations, cross-functional problem solving, and reporting for site metrics and management reviews. The successful candidate will guide investigation processes, oversee the Site Quality System, mentor staff, and support external audits and Health Authority inspections.

Qualifications

• BS degree and 10+ years of experience in a GMP environment.
• Working knowledge of cGMP and Quality Systems.
• Understanding of change control and regulatory expectations related to change management.
• Strong communication and technical writing skills.

Responsibilities

• Lead complex investigations, identify trends and propose CAPA actions.
• Represent QA in deviation triage and containment actions to minimize risk.
• Facilitate cross-functional problem solving for investigations.
• Compile and analyze information for APRs, Management Reviews, and site metrics; present findings.
• Perform PQRs and oversee Potentially Critical Complaints.
• Lead trending assessments to determine corrective actions.
• Provide leadership for Site Quality System elements and training for staff.
• Support external audits and Health Authority inspections.

Skills

Lead investigations

CAPA actions

Cross-functional collaboration

Statistical analysis

Technical writing

Effective communication

Presentation/reporting

Mentorship

Quality systems oversight

Problem solving

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 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.