Director, Validation

Alkermes•Wilmington, OH

2d•Onsite

About The Position

Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, computer systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.

Requirements

Bachelor’s Degree in relatable field required.
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.
Experience and understanding of complex projects and ability to make key decisions based on corporate drivers (best interest of the company).
Work with cross-functional leadership to provide resolutions to technical and/or personnel issues within projects and report issues to senior management and partners when they will have an impact on budget and/or timeline.
Communication skills – must be able to effectively communicate department vision to staff members. Also, must be able to communicate laterally within the quality unit and externally.
Solid organization and problem-solving skills.
Strong leadership ability.
Must be able to provide independent assessment of department with respect to performance.

Responsibilities

Development and oversight of corporate validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement.
Responsible for preparation and management of corporate validation budget which includes clinical and commercial operations support and capital projects.
Mentoring and developing staff which entails selecting and grooming department management team. Also, provide continuous assessment of team and implementation of various training programs to mitigate department weakness with respect to technical and compliance topics.
Participate on various Alkermes quality and technical teams.
Participate in corporate Capital Project Review Team and act as Quality representative.
Develop and utilize department metrics as a tool for continuous improvement.
Clearly define departmental roles and responsibilities with respect to internal and external boundaries.
Provide annual reviews for departmental management team which includes establishment of individual goals and objectives.
Review and approve departmental purchase requisitions.
Translate corporate vision and goals into departmental goals and initiatives and provide oversight for success. Collaboration on site goals and policy creation along with assurance that tactical implementation of goals and policies are adhered to.
Anticipate, analyze, and resolve issues within local Quality department as well as interdepartmentally. Create conditions and emphasize inclusion of all involved departments as necessary.