Quality Assurance Analyst, Sr. - Healthcare jobs in Massachusetts

Role: 

Be Bio is seeking an experienced and motivated Senior Director, Quality Assurance, to establish our Quality Assurance team in support early phase clinical activities.

The Sr. Director, Quality Assurance will be responsible for implementing GxP (GCP/GLP/GMP) compliant Quality Management Systems, performing all required functions of the Quality Unit (ie product release) and building a Quality Assurance organization that fosters a strong Quality culture at Be Bio. This position will partner equally with both internal and external stakeholders and partners (CROs, CDMOs).

Responsibilities:

• Responsible for the strategic development and execution of Be Bio’s quality assurance programs.
• Responsible for all independent, quality-related decisions
• The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing Be Bio’s platform
• The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions
• Collaborate with cross functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate
• Establish and manage Quality and Compliance Training program for GxP employees and contractors
• Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions.
• Establish GxP Vendor Qualification program in accordance with regulatory expectations.
• GxP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
• Ensures robust Patient Traceability COC/COI process for autologous cell therapy programs
• Ensures quality metrics comply with best industry standards and practices, and maintains effective quality governance and continually improves governance to meet organizational and compliance needs
• Interprets and applies quality requirements and provides guidance and training to ensure that company and its GxP vendors maintain an ongoing state of compliance

Experience, Education, Specialized Knowledge, and Skills:

Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal skills, ability to develop important relationships with your stakeholders, and being an all around good company citizen are essential.

• BS/BA in Chemistry, Biology, Pharmaceutics, or other science related field with at least 15 years’ experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
• Prior cell therapy and/or gene therapy experience
• Knowledge of FDA, EU, ICH requirements for GLP and related areas, e.g., 21 CFR Part 58, Part 11 / Annex 11, OECD Principles of Good Laboratory Practices and GLP Compliance Monitoring, etc
• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in leading successful regulatory international inspections
• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others
• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations
• Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment