Quality Assurance Manager at Precision for Medicine in Boston, MA

Precision Medicine Group, LLC is the leading global provider of precision medicine research services and creative commercialization solutions for life sciences companies. After completing the largest private investment raise of a life sciences services company in 2012, we have rapidly grown through a series of acquisitions and 20%+ annual organic growth to more than 2,100 people in over 34 offices across the U.S., Canada and Europe. We are unusually positioned for continued growth as we expand the company’s global footprint and develop leadership in the most creative areas of life sciences as we help our clients develop and deliver lifesaving medical treatments to patients across the world.

Precision for Medicine develops assays and runs global logistics for Clinical Trials by using biomarkers to stratify patients, incomparably improving R&D efficiency and success for our clients. We lead every aspect of clinical trials from sites to biomarkers to diagnostics, dramatically accelerate our clients pathway from proof of concept to drug approval.

We are a great fit for high-energy, dedicated team members who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and collaborating to deliver phenomenal work, we have an opportunity for you.

Quality Assurance Manager - the role:

Are you collecting and interpreting data, spotting trends and noticing outliers? Are you training staff on quality systems? Are you skilled at identifying problems and offering up creative solutions to ensure efficiency and quality?

As an experienced Quality Assurance Manager, you will be responsible for building, implementing, and maintaining our quality assurance systems and processes in compliance with FDA and GxP requirements. By teaming up with the Senior Director of Quality Assurance, you will plan the direction of resources and activities of the quality and compliance functions, including oversight and support of the Quality System and support the quality functions of all critical operations. Leading all aspects of quality across cGxP applications and quality system functions will provide you opportunities to regularly engage with internal teams, clients, and other Precision for Medicine facilities to plan and ensure harmonization of global processes and procedures.

How you will make a difference:

• You will lead and maintain GxP audit programs and inspection readiness activities collaborating with the Senior Director, QA on status of the quality system, compliance status and overall performance.
• You will manage quality system activities adding insights to the evaluation and mitigation of program risks and notification of potentially significant quality issues
• You will host external regulatory agency and notified body assessments and inspections (example: FDA, CAP) and review/participate in issues and/or decisions related to assessments
• You will build, revise and coordinate our controlled document system
• You will plan, promote and organize training activities related to operations, quality assurance, and compliance
• You will lead the review of computer systems, process and equipment validations and re-validation in line with established company policy

What you will need:

Minimum Required:

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

Other Required:

• Excellent knowledge of medical research processes, laboratory testing protocol, and safety requirements
• 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
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• 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
• This position will require occasional domestic or international travel, including overnight stays (up to 20%)
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

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