Director, Validation
Company: Alkermes
Location: Wilmington
Posted on: July 14, 2025
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Job Description:
Director, Validation Overview 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, automation 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. Responsibilities Development and oversight of
site 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 side
validation budget which includes clinical & commercial operations
support and capital projects. Mentoring and developing staff which
entails selecting and coaching department management team. Also,
provide continuous assessment of team and implementation of various
training programs to improve the validation program with respect to
technical and compliance topics. Participate on various Alkermes
quality and technical teams as Validation SME. 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. Qualifications 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 quality 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 quality,
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. About Us Why join Team Alkermes? Alkermes
applies its deep neuroscience expertise to develop medicines
designed to help people living with complex and difficult-to-treat
psychiatric and neurological disorders. A fully-integrated, global
biopharmaceutical company, headquartered in Ireland with U.S.
locations in Massachusetts and Ohio, we are committed to pursuing
great science, driven by deep compassion to make a real impact in
the lives of patients. Alkermes has a portfolio of proprietary
commercial products for the treatment of alcohol dependence, opioid
dependence, schizophrenia and bipolar I disorder, and a pipeline of
clinical and preclinical candidates in development for various
neurological disorders, including narcolepsy. Beyond our important
mission of developing medicines to address unmet patient needs, we
actively seek to foster a culture of diversity, inclusion and
belonging throughout our business. We strive to ensure that all
voices are respected and valued, recognizing that our diversity of
thought, background and perspective makes us stronger. We are proud
to have been recognized as an employer of choice by many national
organizations, including being certified as a Great Place to Work
in the U.S. in 2024, honored as a Healthiest Employer in both Ohio
and Massachusetts in 2023, a Best Place for Working Parents in
2023, and to have received the Bell Seal at the Platinum level for
Workplace Mental Health by Mental Health America for three
consecutive years (2021-2023). Alkermes, Inc. is an equal
employment opportunity employer and does not discriminate against
any qualified applicant or employee because of race, creed, color,
age, national origin, ancestry, religion, gender, sexual
orientation, gender expression and identity, disability, genetic
information, veteran status, military status, application for
military service or any other characteristic protected by local,
state or federal law. Alkermes also complies with all work
authorization and employment eligibility verification requirements
of the Immigration and Nationality Act and IRCA. Alkermes is an
E-Verify employer.
Keywords: Alkermes, Newark , Director, Validation, Healthcare , Wilmington, Ohio
