Reporting to the Vice President of Quality and Regulatory Affairs, the Director of GMP Quality Assurance will direct and provide leadership for all CMC activities of the Quality Assurance Department. This is a leadership/management position responsible for overseeing the GMP components of the Berg Quality Management System (QA review and approval, compliance activities, product release activities, quality systems, document control, and developing the strategy and policies of the GMP QA department). The position will provide quality oversight of Berg’s innovative investigational drug products for clinical sites per applicable cGMP, FDA, and other regulatory agency standards. Berg seeks an adaptable, disciplined, and dependable individual with both clinical and commercial experience.
The Director of GMP Quality Assurance will manage personnel, equipment and resources to support department objectives. Duties will include:
Serve as resident cGMP QA expert in support of CMC activities
Working with Berg Regulatory Affairs establish regulatory compliance strategies based on industry trends and regulatory compliance citations
Ensure products manufactured are in compliance with regulatory expectations and in alignment with all regulatory submissions
Perform Release activities for clinical trial material
Support change management, CAPA, deviations, and investigation programs
Support the manufacturing department on new products, changes to products, processes, and services to achieve a consistent approach to quality utilizing ICH Quality-by-Design (QbD).
Support effective and efficient continuous quality and cost improvement efforts utilizing QbD and development of design control strategy.
Hire, train and develop QA and QC staff and conduct performance evaluations to assure highly effective, team-oriented contributors to the Company’s success
Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance
Performing other duties as may be required or necessary
Requires a BS or BA in a scientific or related field from a four-year college or university with ten (10) or more years of biotech/pharma industry experience, including QA and/or Regulatory Affairs
Experience in a pharmaceutical manufacturing environment; excellent knowledge of cGMP, ICH, ISO, USP and global compendial regulations and guidance's, particularly as related to analytical method development and validation
Contract Manufacturing Organization(CMO) or Contract Development Manufacturing Organization (CDMO) experience desirable
Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports
Ability to assign resources according to project priority and complete tasks by the assigned timeline
Proficient in Microsoft-based computer software programs: Word, Excel, Project, Powerpoint, Visio, and Google applications such as Mail and Drive.
Effective team builder with demonstrated abilities to lead and motivate all levels of personnel
Problem Solving - Looks beyond the obvious and doesn't stop at the first answers
Uses rigorous logic and methods to solve difficult problems with effective solutions
Extensive auditing experience
Strong analytical and problem solving skills
Effective writing and verbal communication skills
Able to work flexible schedules to complete assigned department tasks
BERG is a Boston-based biopharma company focused on taking a bold “back to biology” approach to therapeutic discovery using its unique AI-based Interrogative Biology® platform. This platform combines patient biology and artificial intelligence-based analytics to engage the differences between healthy and disease environments. The patient’s own biology drives the platform’s results and guides us in... the discovery and development of drugs, diagnostics and healthcare applications. Our platform utilizes patient population health data to bring actionable Patient IntelligenceTM to precision medicine applications. This means faster discovery and development of treatments, more effective precision treatments for individuals as well as a reduction in costs to our healthcare systems.