Quality Assurance, Senior Associate, Third Party Quality

VIATRIS ASIA PACIFIC PTE. LTD.; Town of Islip (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading global company is seeking a Quality Assurance Snr Associate to ensure regulatory compliance and quality management across contract manufacturers. This highly independent role requires minimal supervision and involves interacting with various levels of management while providing quality leadership and support for product launches. With a focus on maintaining high-quality standards and compliance in a dynamic environment, the ideal candidate will possess strong communication skills and a solid background in regulatory affairs.

Qualifications

• Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with a Masters degree).
• Advanced in computer skills such as MS Office applications.
• Good command of English; multilingual is a benefit.

Responsibilities

• Provide quality assurance & regulatory compliance management for key contractors.
• Lead and support QA/QC systems for products processed by CMOs.
• Manage customer and product complaints and oversee investigations.

Skills

Verbal communication

Written communication

Negotiation

Multi-tasking

Customer focus

Education

BA/BS in Science, Engineering, Pharmaceutical Sciences or related field

Tools

SAP

Trackwise

Documentum

Job description

Position Summary:

Viatris Third Party Quality (TPQ) is committed to supporting Viatris Global Integrated OSD and API External Supply Organisation as an innovative and competitive advantage for Viatris by assuring the quality of legacy Upjohn products manufactured and packaged by other companies (Contractors) for Viatris.

Viatris Third Party Quality is responsible for the Quality management of over 100 contract manufacturers, packagers, and supply partners globally, covering approximately 7,000 SKUs in 165 markets.

Position Responsibilities:

The Quality Assurance Snr Associate is accountable for providing quality assurance & regulatory compliance management of key contractors in the Global Integrated Oral Solid Dose (OSD) and API External Supply portfolio and for assuring that the products supplied to our patients are manufactured, tested in accordance with cGMPs, the registration file and any additional country specific requirements.

This is highly independent position operating with minimal supervision, interacting with various levels of management both at contract manufacturers and within Viatris. (S)he will operate as spokesperson for Third Party Quality and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Viatris quality & regulatory requirements with contract manufacturers.

The Quality Assurance Snr Associate will have interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Global Quality, Internal sites and R&D) and will lead and participate in virtually based cross functional teams. (S)he will report to the Snr Manager, Contract Quality Lead, Viatris Third Party Quality. Key responsibilities include but not limited to:

· Provide quality assurance and regulatory guidance for technical changes and quality events at Contract Manufacturing Organizations (CMO’s).

· Participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/TPQ managed Contract manufacturers & participate in Site Quality visits at the Contract manufacturers, if needed.

· Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).

· Initiate, review and approve regulatory changes in the regulatory systems for changes initiated by or impacting TPQ managed Contract manufacturers.

· Serve as a TPQ point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Viatris Country Offices (for Single market products) for the various regulatory activities involving TPQ managed Contract manufacturers.

· Prepare Critical Quality Event (CQN) summaries and participate in relevant meetings.

· Provide Quality Leadership and author support documentation for individual market release supporting documents to meet local regulatory requirements.

· Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.

· Lead the development, implementation and support of QA/QC systems for products processed and produced by CMOs

· Support new product launches and technology transfers.

· Act as liaison between regulatory and CMO for generation of filing information for these projects and review the associated regulatory submission documents, Product registrations and Post approval variations.

· Participate in Virtual Project team meetings, as required

· Manage Customer and Product complaints and work in collaboration with the TPQ Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per procedure.

· Support and Perform SAP Lot Disposition, if required

· Lead and/or provide support to other quality projects and continuous improvement initiatives within TPQ and External Supply, as required.

· Perform and assist with additional duties as may be directed by Snr Manager, Contract Quality Lead.

Qualifications:

· Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline

· Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree)

· Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as SAP, Regulatory systems, Trackwise, Documentum platforms

· Good command of English language and multi-lingual is a benefit

· Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment

· Able to work remotely and deliver work independently

· Show strong negotiation skills and customer focus

· Is diplomatic in communication with internal and external customers

· Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader

· Take initiative and be proactive

Travel Requirements:

· Up to 20 % travel may be required