Manager/TL Quality Control, Stability

Viatris Pharmaceuticals LLC

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 Manager/TL Quality Control Stability role will make an impact:

Key responsibilities for this role include:

The Manager/TL Quality Control, Stability is responsible for the administration of the stability Quality Control analytical laboratory and personnel. Interprets and assures that cGMPs, GLPs and applicable regulations are followed in the stability laboratory.  Work together with the other QC Managers to maintain effective and efficient laboratories that consistently meet regulations.

Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Essential Duties and Responsibilities

• Develops a quality control organization for the stability testing operations that can assure product conformance with company and regulatory requirements.
• Directly responsible for the development and implementation of Quality Control Systems and Procedures in the QC Stability Laboratory.  Responsible for the review and approval of operational procedures as applicable.
• Is responsible and provide guidance to QC Laboratories TL/Supervisors and areas personnel in resolving Quality events.
• Reviews/approves new and revised finished product, raw material, and packaging specifications as appropriate.
• Ensures the development, effective implementation, maintenance, and monitoring of the quality management system include reconciliation and approval of written procedures, amendments thereto and other documents.
• Reviews and evaluates stability protocols and reports, technology transfer protocols, product summaries for new or transferred products and equipment, and facilities qualification protocols and reports, as required.
• Ensures analytical standard test procedures, NDA’s, ANDA’s and specifications are followed for stability laboratory testing and are consistent with corporate and divisional policies.
• Ensures procedures are followed for the stability sample selection, receipt evaluation, pull testing, analytical data review, trends evaluations, stability tables reporting, storage and dispositions of raw data.

• Responsible of maintaining informed the Senior Quality Management of any quality, safety and supply issues and participate in the management review of processes, product quality and quality management system as well as support for continuous improvement following procedures.
• Provides guidance and direction during investigation of questionable results or out of specification results to the Quality Control Laboratories TL/Supervisors and informs department head of any incident.  Ensures final approval of the analytical results to be filled as part of the annual stability reports to the regulatory agencies.
• Responsible for the integrity of systems and data generated by the QC Stability Laboratory.
• Participate in the evaluation of proposed changes to the Pharmacopoeias and the updates of the analytical test methods and specifications as per current Pharmacopoeias.
• Assure changes are made conducting the required testing (including microbial testing when applicable) of stability program API and finished products.
• Ensures that the stability samples storage areas have adequate controls to minimize the impact of any unexpected environmental event.
• Responsible for providing stability testing services and technical support to Viatris development teams on new products.
• Develops and reinforces with key quality control personnel effective goal setting, both short and long term, to ensure that quality performance is maintained at optimum level following quality goals.
• Reinforces a quality philosophy with location management to assure that product meets established company specifications and promotes the Company Values.
• Ensures that adequate standards of safety, health and environmental (EHS) exist regarding personnel, facilities, and equipment within the quality control department.  Participates in the Safety Program as established by the Environmental, Safety & Health Department.
• Assists during regulatory inspections (FDA, OSHA, DEA, Department of Health, etc.).
• Ensures that all environmental practices applicable to his/her respective areas of responsibility are followed according to area SOPs and company environmental compliance policies and guidelines.
• Ensures Controlled Substances procedures are executed according to DEA regulations and following internal SOP’s.
• Provides support and meet regulatory compliance for Dangerous Good, Alcohol, and Tobacco Tax and Trade Bureau compliance.