Dir, Validation

Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support. Develop and oversee site validation program to ensure compliance with cGMPs, FDA and EU guidelines.

Requirements

• Bachelor’s Degree in relatable field
• 12+ years’ experience in cGMP pharmaceutical manufacturing environment
• Supervisory Experience: minimum of 6 years
• Working knowledge of Quality Systems
• Detailed knowledge of all aspects of validation
• Detailed working knowledge of GMPs, FDA Aseptic Processing Guideline, EU “Orange Book”, GAMP, and ICH guidelines
• Communication skills
• Solid organization and problem-solving skills
• Strong leadership ability

Benefits

• Life insurance
• Retirement plans
• Health insurance
• Paid time off
• Stock options