Senior Manager, Quality Assurance - GxP

PTC Therapeutics

Dublin, Ireland

Job Description Summary:

The Senior Manager, Quality Assurance - GxP is responsible for conducting audits with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for PTC commercial and clinical activities in both the small molecule and large molecule space.

This involves engaging and collaborating with cross functional internal teams to evaluate CMC processes, procedures, and activities for adherence to relevant industry standards, regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

She/He may manage direct reports.

Responsibilities for the role include:

The incumbent works cross-functionally with internal departments and external resources on GxP QA related issues;
The Senior Manager, Quality Assurance – GxP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate:
- Contributes to and executes PTC’s GxP risk-based audit strategy to achieve compliance with applicable current regulatory requirements;
- Performs internal and external audits as assigned to ensure compliance with GMP and GDP regulations (may include internal processes, Contract Manufacturing Organizations (CMOs), laboratories distributors, and other vendors):
  - Communicates audit results to stakeholders and writes audit report;
  - Assesses audit responses and ensures closure of corrective and preventative actions (CAPAs).
Leads backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities;
Supports Quality Management System (QMS) including, but not be limited to, the following activities:
- QA review/approval of deviations, CAPAs and change controls.
Drafts, reviews, and approves SOPs;
May manage, coach, and mentor direct reports;
Performs other tasks and assignments as needed and specified by management.

Requirements for the role include:

Bachelor’s degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance, Regulatory Affairs, Manufacturing, or a related role in a pharmaceutical, biotechnology or related environment;
Demonstrated ability to work as a team player: listens, promote exchanges, communicates, adapts and advises;
Detailed knowledge and understanding of GMP regulations;
Demonstrated experience leading and/or conducting audits;
Demonstrated experience executing risk-based audit plans;
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors;
Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports;
Experience supporting regulatory agency inspections;
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;
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects;
Knowledge and experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP);
Registered GxP Quality Assurance Certifications.