Director / Assoc. Director of Inspection Management
A highly successful pharm company in Munster has a new vacancy for Director / Assoc. Director of Inspection Management. The successful candidate will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.
Responsibilities will include: -
• Benchmark leading practices and recommend improvements
• Maintain and organize inspection readiness content
• Build and implement tools to improve IOPS inspection readiness.
• Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
• Work closely with other regulatory compliance team to close gaps
• Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters.
• Respond to incoming inquires during inspections and audits and ensure timely and accurate responses.
• Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
• Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.
• Interfaces with customer/partner quality organizations.
• Participates on internal committees/teams, as required.
• Provides advice and direction to other company departments on quality and regulatory issues.
The Ideal Candidate:
- You are analytical, strategic, pragmatic, quick thinking and possess a “big picture” mentality.
- You can lead multiple, sophisticated projects and changing priorities.
- You can empower and influence
- You will have a BA/BS degree in chemical engineering/chemistry/life sciences, process engineering or validation.
- Have at least 10 years of relevant experience in a biotech or pharmaceutical environment.