Manager, Quality Assurance (QA)

Location
Boston, MA
Salary
TBD
Posted
Jun 29, 2021
Required Education
Bachelors Degree
Position Type
Full time

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
  • Other duties as assigned

Minimum Acceptable Qualifications

Education

  • Bachelor's degree in biology, chemistry, biochemistry, or other scientific discipline

Experience:

  • 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

Skills:

  • Strong working knowledge in all or an area of FDA and EPA Good Laboratory Practice (GLP) regulations, Organisation 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

Working Environment

  • Primarily office (e., blend of office and work from home)
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
  • Work may require occasional travel

Physical Demands

  • Ability to work in an upright and/or stationary position for up to eight (8) hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
  • Occasional mobility needed
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moving) objects, including luggage, office supplies, and laptop computer, with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance