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GENERAL SUMMARY OF POSITION: 

The Quality Assurance Manager is responsible for managing the development, implementation and maintenance of quality systems for commercial and investigational mulit-product biologics manufacturing facilities, producing in-house and contract manufacturing drug substance, drug product and cGMP services.  Working as a leader with the Quality Group the incumbent may lead a team of Quality expert and technical staff or contribute as a project manager, consultant, technical expert or technical writer as required.

MAJOR RESPONSIBILITIES:

• Support the senior leadership of QA and/or QC in the day to day operations of the quality group including but not limited to authoring, revising and approving controlled documents, participating in the Investigative Report system, CAPA system, Change Control System, Internal and External Audi Systems.
• Provides technical input to the Quality System with minimal supervision or oversight.
• Maintains technical knowledge related to all procedure for testing, manufacturing and assurance processes at MassBiologics.
• Assists with Investigating, writing, reviewing and/or approving incident/deviation reports, out-of-specifications reports and other technical reports as needed.
• When required hires, manages and trains staff, plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
• Assists Quality group leadership in the development of and adherence to budget. Assists with the development of and adherence to project timelines, including CMO projects and change management project.  May represent the Quality Group at the organizational level for purposes of operational management and planning.
• Perform other additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a scientific discipline or equivalent.
• 5 years of relevant experience including management experience.
• Clear, concise, written and verbal communication and presentation skills
• Demonstrated problem-solving skills.
• Ability to maintain extensive working knowledge and proficiency in applicable cGMP regulations and all current Quality Control procedures within a particular functional area (e.g. microbiological methods for environmental / facility testing, as well as both licensed and IND products)
• Ability to motivate personnel to work effectively and efficiently.
• Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluations
• Experience in at least three of: cGMP compliance systems, cGMP training systems, cGMP auditing systems, cGMP vendor management, quality control chemistry. quality control microbiology, bioassay including in vivo testing, aseptic manufacturing, visual inspection of parenteral products, CMO management/quality agreements, cGMP validation, international cGMP regulation, management of multiproduct faciltiies, and biosafety/hazard management.
• Requires ability to work flexible and, at times, extended hours to meet business needs

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