Senior Manager, Quality Assurance

Position Summary

The Senior Manager, Quality Assurance 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:

• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements
• Host client, external regulatory agency, and notified body assessments and inspections (example: FDA, CAP). Review and participate in issues and/or decisions related to assessments
• Estimate and administer budget schedules and performance standards
• Serve as system owner for a global QMS functions as they pertain to the Frederick site to include process mapping, aligning global practices, promoting improvement, leading and maintaining compliance, and measuring and reporting on performance and effectiveness through established metrics and KPIs
• Review and approve quality system activities (including but not limited to Deviation, Non-Conformances, Customer Complaints, CAPA, Audits, Validation, Qualification, Equipment, Review and Disposition of final product/data)
• Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements
• Serve as the site management representative, providing updates to the Head of Global Quality for Translational Laboratories regarding status of the quality system, compliance status and performance relating to quality
• Manage the Quality System and support the quality functions of all critical operations
• Plan and direct resources and activities of the quality assurance and compliance functions in conjunction with the Head of Global Quality for Translational Laboratories
• Lead inspection readiness activities
• Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies
• Lead the team of Quality Assurance specialists
• Prepare and lead management reviews of the quality management system for the site and provide inputs to global management review
• 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
• Coordinate and/or ensure annual training for HIPPA, Bloodborne Pathogens, Hazard Communication, and Ergonomics, and Quality Compliance
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations
• Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
• Site head of Quality Assurance at the Frederick, MD location of Precision for Medicine
• Plan, promote and organize training activities related to operations, quality assurance, and compliance
• Quality Assurance representative on the Frederick site leadership team
• Collaborate with operational and quality staff in other Precision locations to execute harmonization plans for global processes and procedures to be implemented and maintained at the Frederick, MD facility
• Advise staff to help meet established schedules or resolve technical or operational problems
• Other duties as assigned

Qualifications

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• 8 years of experience as a Quality professional in the biotechnology or life science, regulated environment

Other Required

• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Extended business hours may be necessary in order to meet the business demands
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• Excellent knowledge of medical research processes, laboratory testing protocols, companion diagnostics, and safety requirements
• This position will require occasional domestic or international travel, including overnight stays (up to 20%)
• Must be able to read, write, speak fluently and comprehend the English language
• Strong understanding of medical data collection, record keeping, and reporting requirements
• Experience interpreting and complying with world-wide cGxPs with an emphasis on GMP, GCP, GLP, GCLP, and blood establishments

Preferred

• ASQ or SQA certification desirable (obtain certification within first year)
• Master’s degree in Physical, Biological Sciences, or technical/scientific field

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

$120,000 — $160,000 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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