Senior Quality Compliance Manager Pharma EU & FDA

Location
Dublin North
Salary
Negotiable Depending on Experience
Posted
21 March 2019
Closes
18 April 2019
Ref
AACMA
Position / level
Manager, Professional
Contract Type
Permanent
Hours
Full Time

JOB DESCRIPTION

We are looking for a quality compliance manager to take up a senior role (without direct reports) within a well-known international pharmaceutical company. Reporting to an associate director you will be responsible in leading the compliance team from the perspective of auditing, managing high-risk sites, maintaining audit readiness, implement and maintain compliance guidance across the business, and provide supplier oversight with a view of supplier risk alert reduction. If you have manufacturing and QA experience as well as knowledge of US & EU cGMP and ICH guidelines, you might be a suitable candidate for the role.

This role will involve significant international travel however, the global audit teams have a 2-cycle yearly pattern. Thus you will know the international schedule 5/6 months ahead, and this, of course, will have flexibility.

Responsibilities of the Job

  • Independently or through leading a team conduct, and report external foreign and domestic audit activities of a complex nature, such as API, Due Diligence, Sterile Production, and any other new technology audits.
  • Lead internal audits of all sites and acquisitions.
  • Lead and guide mitigation activities for company suppliers across one or more company sites.
  • Provide technical guidance and leadership to local plant Quality Operations functions by assessing, troubleshooting and recommending solutions to resolve complex compliance issues.
  • Contribution to/Leadership of companywide harmonization efforts, e.g. supplier management, audit tracking modules, and training modules / programs.
  • Stay current and provide direction with Regulatory and Industry compliance trends and develop new auditing strategies as appropriate.
  • Lead synergies between the Corporate compliance group and internal and external quality and manufacturing groups.
  • Collaborate with business partners and vendors to develop lasting relationships that help strengthen and assure communication between parties while assuring highest quality material/service
  • Manage quality compliance projects as directed by management

Requirements to Qualify for the Job

  • Minimum of 7+ years related pharmaceutical, medical device or biologics experience in manufacturing, quality assurance, or GMP/ISO/Quality auditing. You would need to have any given mix of these, however ideally this individual will have a background in auditing Medical Device and Biologics GMP facilities.
  • Experience in leadership of team or project activities.
  • Superior Knowledge of U.S. cGMPs, Device or Biologic regulations and FDA guidance.
  • Superior Knowledge of EU GMPs, Device or Biologic regulations and ICH guidance’s and International Standards (Risk Management, ICH 8, 9, 10)
  • In-Depth Knowledge of other International GMP, Device or Biologic regulations (ANVISA, Japan, Canada etc.), is a bonus.
  • Advanced Knowledge of drug, device or biologic manufacturing, packaging, laboratory, and warehousing operations.
  • ASQ Certification or similar certification as a Quality Auditor, Manager or Engineer a plus. 

Contact

If you are interested in this job apply below. I also have more senior or indeed junior roles within Engineering, QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, biologics, and food companies. Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius@sigmar.ie