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Actalent · 2 days ago
Director, Quality Operations
Cambridge, MA
Full-time
Onsite
Director
10+ years exp
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Responsibilities
Oversee the disposition of in-process materials and finished products.
Handle labeling and documentation, manage deviations, CAPAs, and product complaints.
Manage the system for controlled documentation and oversee supplier management.
Conduct internal audits and work closely with project and product managers.
Align department objectives with business goals and establish key performance indicators.
Participate in cross-functional project teams and recommend process improvements.
Develop organizational policies and work on complex issues.
Ensure schedules meet corporate requirements and interact with project and product managers.
Align department objectives with site business objectives and participate in cross-functional projects.
Maintain and report applicable department or organizational metrics.
Contribute to the evaluation and mitigation of program risks.
Develop, interpret, and execute organizational policies.
Provide recommendations for process improvements and work on moderately complex problems.
Perform other duties as assigned.
Qualification
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Required
Bachelor’s degree with a minimum of 14 years of experience in a biotech or pharmaceutical regulated industry (minimum of 10 years in Quality/8 years directly related to management of personnel). Prior leadership experience required.
Master’s degree with a minimum of 12 years of experience in the life sciences regulated industry (minimum of 10 years in Quality/8 years directly related to management of quality personnel). Prior leadership experience required.
Strong working knowledge of ICH, FDA, ISO and cGMP regulations.
Excellent technical writing and presentation skills.
Strong leadership and personnel development experience.
Excellent communication skills at organization, team and individual levels.
Preferred
Prior Medical Device Experience Required
Proficient in Auditing, both internal and vendor
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
Company data provided by crunchbase
