Director, External Capabilities

The Analytical Research & Development (AR&D) Compliance Center of Excellence (CoE) department of our Our Research Laboratories Division is seeking applicants for a director leading an analytical metrology and validation team at our European research facilities in Dunboyne, Ireland and Werthenstein, Switzerland.

The External Capabilities & Compliance Director will work as part of the integrated Compliance CoE and drive a culture of quality and operational excellence across the global AR&D network. The Director role manages a team of metrology and equipment coordination specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP environment. In addition, this role will require oversight of externalized analytical testing partnerships, working closely with the Analytical External Capabilities teams in the region.

The key responsibilities of this role will include:

- Managing and coaching a team of specialists across our European sites
- Collaborate with scientific teams across AR&D and external partner groups to drive compliance and operational excellence
- Oversee the maintenance and qualification of laboratory equipment and instrumentation in both GMP and non-GMP environments
- Support internal and external quality audits and maintain laboratory state of permanent inspection readiness
- Where required, support vendor relationship management for analytical external partnerships

**Secondary** Language(s) Job Description**:
**Education Minimum Requirements**
- Ph.D. in analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 5 years of relevant experience;
- OR M.S. with a minimum of 8 years of experience;
- OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.

**Required Experience and Skills**
- Experience leading a team
- A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives
- Proven track record of strong technical and innovative problem solving
- Desire and ability to learn new concepts outside of core expertise and training
- Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
- Related industry experience with metrology and equipment maintenance and calibration.
- Experience working within a GMP environment.
- Understanding of GMP policies and procedures.

**Preferred Experience and Skills**

While not required, experience in one or more of the following areas is beneficial.
- Demonstrated commitment to diversity and inclusion
- Experience leading a team for a common goal
- Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.
- Experience supporting internal and external quality audits.
- Experience in instrument computer system validation

AR&D

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R251743