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Precision For Medicine · 4 days ago
Director, Quality Assurance
Frederick, MD
Full-time
Onsite
Director
$140K/yr - $190K/yr
10+ years exp
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Responsibilities
Plan and direct resources and activities of the quality and compliance functions across all facilities globally.
Provide oversight to site-specific quality leadership team.
Identify/lead and participate in process improvement initiatives and align global quality systems.
Collaborate with cross-functional operational and quality staff in other Precision locations globally.
Lead Quality responses to requests for information, business development proposals, and attend meetings as required.
Ensure products are in compliance with established specifications and regulations.
Host/support external regulatory agency, client, and notified body assessments and inspections.
Serve as Management Representative designee for management reviews of the quality system.
Coordinate with Learning & Development for required training related to quality assurance and compliance.
Provide input on budget schedules and performance standards.
Schedule and manage process and equipment validations in accordance with SOPs.
Maintain CAPA, nonconformance, QMS electronic documentation, and complaint management systems.
Travel up to 30% including international.
Perform other assigned duties.
Qualification
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Required
Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
10-12 years’ experience working in a Quality driven life science, regulated environment
5 years of supervisory experience
Relevant Industry Certification(s)
Experience interpreting and complying CLIA, CAP, GLCP, FDA QSR, ISO15189, ISO 13485, ICH
Ability to lead and manage a global quality team
Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)
Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
Able to travel both domestically and internationally including overnight stays
Must be able to read, write, speak fluently and comprehend the English language
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision For Medicine
Precision for Medicine is a specialized scientific services company helping life science innovators develop medical products. It is a sub-organization of Precision Medicine Group.
1,001-5,000 employees
H1B Sponsorship
Precision For Medicine 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
2022 (2)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$225M2015-12-22Private Equity· $75M
2013-04-02Private Equity· $150M
Leadership Team
Jared Kohler
Sr. Vice President, Project Management & Data Science Operations & Precision for Medicine
Jay Lezcano
SVP & Business Development
Recent News
2024-06-03
Company data provided by crunchbase
