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Director, Quality Assurance - Frederick, MD, United States - Precision Medicine Group
Description
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics.
We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.
With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
Won't you join us today as a Director of Quality Assurance? Position Summary:This Director of Quality Assurance (Bioservices) role is responsible for planning and implementing the quality systems strategy including organizational resource planning, implementation of technology, and developing and implementing tactical plans to meet Company objectives.
Essential functions of the job include but are not limited to:Plan and direct resources and activities of the quality and compliance functions across all facilities globally.
Provide oversight to site specific quality leadership teamIdentify/lead and participate in process improvement initiatives and continue the alignment of the global quality systems across the sitesProvide updates to the company leadership regarding status of the quality system, compliance status and performance relating to qualityCollaborate with cross-functional operational and quality staff in other Precision locations globallyProvide oversight of the global Quality Management Systems that support the quality functions of all critical operations including laboratories, supplier qualification, clinical trials, including commercial diagnostic productsLead Quality responses to request for information, business development proposals and attend business development meetings as requiredDirect application of the Quality Management Systems in assuring that components and finished products are in compliance with established specifications and regulations.
Responsible for release of all products manufactured and results released from commercial diagnostic products.Ensure participation in project team meetings as a Quality representative and contribute toward development of relevant design control and risk management documentation for commercial diagnostic productsHost/support external regulatory agency, client and notified body assessments and inspections (example:
CLIA, CAP, FDA, ISO, EMA, ).
Review and participate in issues and/or decisions related to assessmentsEnsure a technical liaison between Quality and all other functional management groups in terms of operational objectives, with respect to quality.
Serve as Management Representative designee responsible for ensuring periodic management reviews of the quality system are conductedCoordinate with Learning & Development to ensure that all applicable, required training is provided as related to product/service quality, quality assurance, and complianceProvide input budget schedules and performance standards as neededSchedule and manage process and equipment validations and re-validation in accordance with established Standard Operating ProceduresComplete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirementsMaintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systemsTravel up to 30% including internationalOther duties as assignedQualifications:Minimum Required:
Bachelor's Degree in Physical, Biological Sciences, or technical/scientific field10-12 years' experience working in a Quality driven life science, regulated environment5 years of supervisory experienceRelevant Industry Certification(s)
Other Required:
Experience interpreting and complying CLIA, CAP, GLCP, FDA QSR, ISO15189, ISO 13485, ICH,Ability to lead and manage a global quality teamExperience 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 systemsMust 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 staysMust be able to read, write, speak fluently and comprehend the English languagePrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to:skill sets, experience and training, licensure and certifications, and other business and organizational needs.
The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range$140,000—$190,000 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy.
For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at
