Manager, Quality Assurance

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our Boston team and ensure overall GxP compliance. The ideal candidate will have a background in data auditing and a proven ability to manage QA systems effectively. Responsibilities include developing, implementing, and overseeing QA protocols, conducting thorough inspections of plans, data, reports, and in-lab phases, and managing and mentoring QA team members at our Boston facility. This role is pivotal in maintaining the highest standards of quality and compliance within our organization.

Essential Responsibilities

• Develops, implements, and manages QA systems as detailed in the QMS; conducts periodic reviews of QMS and implement corrective actions
• Leads/performs plan, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOPs, protocols, and regulatory requirements
• Writes QA SOPs and provides regulatory input for other department SOPs
• Assists or hosts sponsor audits and government agency inspections
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
• Notifies management of quality/compliance trends and service failures
• Monitors regulatory and industry trends/actions and reports regularly to QA management
• Interfaces with internal departments, external customers, and regulatory entities regarding compliance needs, issues, and status
• Obtains and maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, and establishing personal networks
• Provides leadership to team of QA Auditors (as applicable); recruits, selects, and trains employees while providing growth opportunities
  
  
  
  
  

Additional Responsibilities

• Other duties as needed
  
  
  
  
  

Minimum Preferred Qualifications: Education/Experience

• Bachelor’s degree in biology, chemistry, biochemistry, or other scientific discipline
• Not less than two (2) years’ experience working in a laboratory/bench role
• Not less than six (6) years’ experience in GLP/GCLP quality assurance (QA)
• Not less than eight (8) years’ experience working in pharmaceutical, biotechnology, CRO/CMO or similar organization
• Not less than two (2) years’ experience managing staff or QA processes
  
  
  
  
  

Minimum Preferred Qualifications: Skills

• Strong working knowledge in all or an area of FDA and EPA Good Laboratory Practice (GLP) regulations, Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice, FDA Good Clinical Practice (GCP) regulations, Good Clinical Laboratory Practice (GCLP) principles, and/or FDA Good Manufacturing Practice (GMP) and industry standards as they apply to the life sciences and pharmaceutical industries
• Experience in coordinating government/regulatory agency and sponsor inspections
• Experience in organizing and directing a cross-functional team to ensure compliance with applicable regulations for all compliance activities undertaken
• Versatility, flexibility, and willingness to work within constantly changing priorities
• Strong organizational skills that reflect the ability to perform and prioritize tasks; ability to work in fast-paced, deadline driving environment where multiple projects must be completed in a timely manner
• Ability to deal effectively with diverse individuals at all organizational levels
• Excellent communication skills, both oral and written, with ability to present views in a clear and concise manner; ability to communicate in a proactive and solution-focused manner
• Strong interpersonal skills with the ability to work effectively with all levels of management and employees in a diverse community
• Demonstrated proficiency with Microsoft applications (i.e., Word, Excel, and Outlook)
• Unquestioned integrity and ethics with a confident but well-grounded approach to doing work
  
  
  
  
  

Position Type and Expected Hours of Work

• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required
  
  
  
  
  

Benefits And Other Perks
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.