Senior Manager, QA Compliance

BMS - Bristol-Myers Squibb

Cruiserath, Ireland

BMS Cruiserath Biologics is seeking to recruit a permanent Senior Manager, QA Compliance who is responsible for oversight and implementation of the regulatory compliance elements of the Quality Management System, the Supplier Quality Management program, inspection readiness program and the Data Integrity program at Cruiserath Biologics. This position is responsible for the recruitment, development, and management of the QA Compliance team and is reporting to the Associate Director, Quality Systems and Compliance.

Key Duties and Responsibilities:

Responsible for the internal audit/self-inspection program at the site - including management of procedures, development of annual schedule, execution of audits and management of response development and remediation. Tracking commitments to completion, identifying trends, and escalating accordingly;
Leads the Site Inspection Readiness Program by liaising with site SMEs, conducting mock inspections as required and tracking completion of all site inspection readiness tasks;
Leads the site Data Integrity program;
Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements;
Responsible for maintenance of the inspection logistics program including administration of ACE system;
Participates as a core team member in any corporate or regulatory agency inspections and supports cross functional teams to develop responses, tracks the commitments to completion;
Point of contact for License Management;
Responsible for the provision of general regulatory compliance support to applicable markets pertaining to regulatory/ filing submissions;
Participates in the product recall and health authority notification process in accordance with BMS procedures;
Responsible for the Site Master File, Supply Chain Flow Maps, and the associated procedures;
Manages the internal compliance program at the site - including review of site procedures relative to BMS corporate policies and directives. Documents impact assessments and track commitments to completion. Escalates site compliance issues accordingly;
Manages Quality oversight of Supplier Quality Management and external audit program as required including reviewing, approving, and tracking corrective actions related to external audits;
Manages the Supplier Quality Agreements program to ensure that raw material suppliers, service suppliers and equipment vendors meet applicable regulatory and company requirements;
Responsible for the supplier non-conformance investigation program and escalation of critical events to senior leadership;
Serves as a Subject Matter Expert SME for internal audits/self-inspection, supplier management, Site Master File, and general site GMP compliance;
Supports the site Quality Management Systems program.

Qualifications, Knowledge and Skills Required:

A degree in a science, engineering or related discipline is essential along with minimum of 10 years’ experience in the biopharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency;
Experience of Leadership and management skills;
Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written;
Strong technical background in biologics;
Understanding of GMP Principles pertaining to Biologics manufacture;
Demonstrates expert knowledge of EU, FDA, ICH and BMS Corporate cGMP policies and guidelines;
Understanding of manufacturing unit operations;
Understanding of Internal Regulatory requirements;
Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

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