Manager, Quality Assurance Jobs

Position Summary

The Quality Assurance Manager is responsible for building, implementing, and maintaining quality assurance systems and processes that comply with FDA and GxP requirements. This individual will oversee and execute all aspects of the strategic quality plan across cGxP applications and quality system functions. This role will interface with internal teams, clients, regulators, and other Precision for Medicine facilities.

Essential functions of the job include but are not limited to:

• Schedule and manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.
• In conjunction with the QA Senior Leadership, plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations.
• Responsible for ensuring management reviews of the quality system are conducted. Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements.
• Advise staff to help meet established schedules or resolve technical or operational problems.
• Extended business hours may be necessary in order to meet the business demands.
• Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO, CAP). Review and participate in issues and/or decisions related to assessments.
• Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies.
• Ensure a technical liaison between QA/QS and all other functional management groups in terms of operational objectives, with respect to QA/QS concerns. Ensure that quality assurance and compliance resources are capable of providing required consultation and input for new projects, development activities and technology transfer.
• Travel up to 20%.
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations.
• Lead inspection readiness activities.
• Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues.
• Manage the Quality System and support the quality functions of all critical operations.
• Coordinate annual training for Bloodborne Pathogens, Hazard Communication, and Ergonomics.
• Plan, promote and organize training activities related to operations, quality assurance, and compliance.
• Create/revise/coordinate controlled document system.
• Estimate and administer budget schedules and performance standards.
• Serve as the site management representative, providing updates to QA Senior Leadership, QA regarding status of the quality system, compliance status and performance relating to quality.
• Participate in cost reduction and improvement programs.
• Collaborate with operational and quality staff in other Precision locations such as Frederick, Maryland, to plan and ensure harmonization of global processes and procedures.
• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements.
• Review and approve quality system activities (Deviation, CAPA, Audits, Data Review and Disposition).

Qualifications

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical / scientific field.

Other Required

• Must be able to read, write, speak fluently and comprehend the English language.
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems.
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• Experience interpreting and complying with world-wide cGxPs with an emphasis on GLP, GLCP, ICH, and CLIA
• 5-8 years of experience as a Quality Professional in the biotechnology or pharmaceutical industry.

Preferred

• American Society for Quality certification desirable.
• Master’s degree in Physical, Biological Sciences, or technical/scientific field.
• Familiarity with Flow Cytometry and ELISpot applications

Precision 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

$105,000 — $150,000 USD

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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, LLC

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