Senior Specialist, Quality Assurance

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access - Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

• Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how this role will make an impact:

Key responsibilities for this role include:

• Manage core activities of the QOO team.

• Quality Management Systems:

• Management of Complaints, Escalations, FAR. Approval of Investigations, OOS, CAPAs.

• Manage and support the Internal Audit Program.

• Vendor Management:

• Support Approval of Vendor/TPM, Carry out risk assessment including assisting in scheduling of Vendor and TPM Audits.

• Support the preparation and control of Technical Agreements and Confidentiality Agreements.

• Product Technical Transfer:

• Act as Quality Subject Matter Expert for Key Product Development and Product Launches.

• Support, Review and Collate data for Technical Transfer and Process Validation including but not limited to data on raw materials, finished product, equipment, process, method validation protocols and reports, and stability protocols.

• Batch Review Coordination:

• Review and Management of Batch review of TPM (Third Party Manufacturers) Manufactures.

• Approval of TPM sites Investigations including laboratory OOS, non-conformances and timely closure of CAPAs,

• Review of Product Quality Reviews where applicable

• Where applicable, Act as Deputy Responsible Person (RP), duties listed in procedure 'Responsible Person Duties and Responsibilities' and include management of authorized activities and the control of Wholesale Distribution, ensuring compliance with EU Good Distribution Practice of medicinal products within EU (GDP directive 2013/C343/01).

• Deputize for the QA Manager (QOO Affiliates) as required

The minimum qualifications for this role are:

• Bachelor's degree (or equivalent) in a Science related discipline with 6+ years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department is essential. Experience of sterile injectable manufacturing and third party site quality management desirable but not essential. However, a combination of experience and/or education will be taken into consideration

• Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, vendor management and batch release.

• Knowledge of Quality Control testing, Advanced knowledge of chemistry, previous HPLC experience (preferably with Empower software) is essential. Experience in troubleshooting within a QC laboratory background is desirable.

• Knowledge of Validation and Aseptic manufacturing an advantage but not essential.

• Knowledge of Pharmaceutical QMS Systems.

• Knowledge of Quality Risk Management Systems.

• Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.

• Knowledge and experience in the use of Data Sharing Software Packages an advantage.

• Excellent organization, communication (verbal and written), interpersonal and presentation skills

• Computer skills i.e., Microsoft Office, Windows etc. Experience in Trackwise, LIMS & SAP would be advantage

• Self-starter with demonstrated efficient and effective work methods and strong initiative

• Strong people management skills with hands on approach to team leadership.

• Position may directly supervise up to 3 employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

• Ability to do all kinds of mathematical calculations and statistical analysis.

• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel may be required.

• Proficiency in speaking, comprehending, reading and writing English is required

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $55,000 - $105,000.

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.