SENIOR COMPLIANCE SPECIALIST
Senior Compliance Specialist
- Independently schedules, 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.
- Plan and strategize long term audit programs and department activities, such as inter facility training, internal site visits, and participate on various companywide teams and projects.
- Provide guidance in managing and controlling the implementation of changes that may impact product quality and regulatory compliance.
- Provide technical guidance and support to local plant Quality Operations functions by assessing, troubleshooting and recommending solutions to resolve compliance issues.
- Contribution to various companywide harmonization efforts, e.g. supplier management, audit tracking modules, and training modules / programs is expected.
- Stay current with Regulatory and Industry compliance trends and adopt auditing strategies as appropriate.
- Minimum Bachelor's degree in a scientific discipline.
- Minimum of 7+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. Medical device industry experience is a plus.
- ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
- Superior knowledge ofU.S.cGMPs and FDA guidance.
- Superior knowledge of EU GMPs and ICH Guidances and International Standards (Risk Management, ICH 8, 9, 10)
- Strong interpersonal skills.
- Effective organizational development skills.
- Excellent written and verbal communication skills.
- Effective influence management and conflict resolution abilities
- Highly developed investigative and reporting skills.
- Effective organization and time management skills.
- Expected to work and grow in a team oriented environment and continue to build synergies between the Corporate compliance group and internal and external quality and manufacturing groups.
- Ability to travel. (40%)
- Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.