Senior Manager QA Projects

Overview

The Senior Manager QA Project is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to represent the site in the Company Regulatory Surveillance initiatives.

As a member of the Quality Leadership Team, the position holder collaborates with other members of the QLT to ensure that on the Couvet site, the Quality Systems are maintained and improved, and that any cGMP compliance issues are duly addressed in a timely manner.

Responsibilities

Essential Job Functions:

• Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site.
• Act within the site’s key projects teams as the main Quality Operations representative and single point of contact for QA, QC, Compliance, and Quality Supplier.
• Contact with the client regarding quality topics, coordinates response/notification to the client related to quality topics.
• Coordinate and drive quality activities related to:

• Technology tech transfer,
• Raw materials introduction,
• Supplier qualification,
• Manufacturing specifications,
• Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).

• multi-site investigations, drive change controls upon requests,
• internal audits (as auditor),
• quality complaints,
• health authority inspections,
• continuous improvement.

Deputy Role for and Deputy Activities

The position acts as deputy of the Site RP for the following quality processes activities under his/her responsibility:

• Release of batches as RP deputy.
• Close out of Critical Complaints.
• Approval of Complaints Extension Requests when an escalated approval is required.
• Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints.
• Approval of documentations related to Suppliers/CSPs qualification and maintenance activities.
• APR/PQR approval.

Qualifications

Experience / Education

• At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or other related industry.
• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or related science.

Knowledge / Skills / Abilities:

• Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
• Demonstrated experience in Regulatory strategies and tactics.
• Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
• Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
• Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
• Excellent interpersonal, collaborative, and organizational skills.
• Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
• High credibility and reliability.
• Excellent investigational and QA problem-solving skills.
• Ability to interpret complex situations with a degree of independence and to articulate recommendations for resolution.
• Drive continuous improvement.
• Knowledge of most common office software and of IT principles.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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