Senior Manager, Quality Assurance- Vendor Management

PTC Therapeutics•Warren, MI

About The Position

The Senior Manager Quality Assurance (QA) - Vendor Management manages and supports PTC’s risk-based vendor qualification program for GxP (GMP, GDP, GCP, GLP, GVP) vendors, suppliers, and service providers and PTC’s Quality Technical Agreement (QTA) system. She/he supports the establishment, management and continuous improvement of Vendor Management QA procedures/processes that ensure appropriate oversight of qualified GxP vendors and related QTAs, as applicable. She/he works cross-functionally with internal departments and external resources and vendors on quality related issues. She/He supports adherence to relevant regulatory requirements, and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Bachelor’s degree in a scientific discipline
A minimum of 7 years progressively responsible relevant experience in pharmaceutical GxP Quality Assurance (QA)/ Quality Control (QC)/ Compliance role
Previous management experience.
Demonstrated proficiency in application of QA principles, concepts, industry practices and standards including Vendor Management QA related activities.
Excellent working knowledge of regulations and sources of regulatory information.
Detailed knowledge and understanding of GMP, GDP and/or Good Clinical Practices (GCP) regulations.
Excellent understanding of production and laboratory systems to effect judgement decisions consistent with business needs.
Demonstrated understanding of international quality systems regulations to adopt best in class systems/processes.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.

Responsibilities

Leads minor projects, supports major projects, and facilitates major project discussion/milestone tracking, involved in the strategic development and participates in the tactical execution of the Vendor Management QA functions.
Development, implementation and continuous improvement of the Vendor Management QA functions that ensure GxP compliance.
Vendor Quality Management QA related functions include, but are not limited to the following: New/Revised/Discontinued vendor requests, Vendor qualification program, Vendor questionnaires, Vendor risk assessments, Vendor approval, Approved vendor list (AVL), Vendor periodic review/requalification, Vendor risk management, Vendor metrics, Vendor health evaluations, Vendor relationship management including vendor issue escalation/resolution working cross-functionally with departments within PTC.
Quality Technical Agreement system.
Ensures the Vendor Quality Management supports and enables compliance with regulatory requirements.
Performs process improvements utilizing recognized quality tools to deliver programs and processes that deliver optimal quality throughout the company processes.
Ensures Vendor Quality Management documentation is compliant and readily available for inspection, regulatory submission or other requirement(s).
Performs assessment/approval of new or changes to vendors in Ariba to determine if they are GxP vendors requiring vendor qualification.
Assure subsequent vendor requests are received in Veeva.
Create or revise SAP Source Lists after review of request consistent with the current Approved Vendor List (AVL).
Works with Global QA colleagues to support change management activities, deviations and/or compliant investigations, batch recall activities etc., as required.
Supports Global QA with GMP/GDP audits of CMOs, contract testing labs and distributors, as required.
Reviews and approves Quality documentation.
Reviews and approves functional area procedures as necessary.
Supports improvement of PTC quality systems and GMP practices.
Identify and make recommendations for improvements to process within the overall Continuous Improvement Process of the Company.
Participates in regulatory inspections and support formulation of audit responses, as required.
Completes all duties as per relevant procedures; ensure compliance to GxP at all times.
Supports other internal Quality departments to ensure departmental success.
Supports Vendor Management relevant activity for other departments (Finance, Procurement, etc.) including source list management and vendor approval in the system.
Performs other tasks and assignments as needed and specified by management.