Performing routine GMP Audits as well as specialty and technical audits related to current products and prospective in-license agreements.
Quality Auditor- North Dublin
Performing routine GMP Audits as well as specialty and technical audits related to current products and prospective in-license agreements. Leading multi-disciplinary audit teams for complex and/or high risk sites. Executing Due Diligence, For Cause and Assessment type audits. Training and qualification of new auditors. Leading compliance guidance and support activities throughout the Organization. Performing Compliance assessments and leading mitigation efforts for Internal and External sites. Supplier Oversight for high risk suppliers. Leading Supplier Risk Alert resolution
- Independently or leading a team conducts, and reports external foreign and domestic audit activities of a complex nature, such as API, Due Diligence, Sterile Production, and any other new technology or specialty facility audits.
- Lead internal audits of all company sites and acquisitions.
- Lead and guide mitigation activities for suppliers across one or more 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 with Regulatory and Industry compliance trends and develop new auditing strategies as appropriate.
- Expected to work, lead and grow in a team oriented environment and continue to build/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
Qualifications and Experience:
- Minimum Bachelor's degree in a scientific discipline.
- Minimum of 7+ years related pharmaceutical, medical device or biologics experience in manufacturing, quality assurance, or GMP/ISO/Quality auditing.
- 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.)
- 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.
Knowledge & Skills:
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
- Highly Effective influence management and conflict resolution abilities
- Highly developed investigative and reporting skills.
- Effective organization and time management skills.
- Strong Leadership abilities
- Highly Effective problem solving skills.
Additional Job Responsibilities:
- Ability to travel. (40-50%)
- Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
- Ability to utilize TrackWise or similar software to manage audit reports
- Provide leadership and resources to ensure ongoing development and performance improvement across Global Compliance Auditing Group
- Assist in preparing for and assessing the readiness of and contract sites for pre-approval and routine regulatory inspections.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.