Vor Bio
Director, CMC Quality Assurance
Vor Bio, Cambridge, Massachusetts, us, 02140
Who we are looking for:
The Associate Director/Director, CMC Quality Assurance will be responsible to act as a key QA CMC lead on program team(s). Candidate will be responsible for planning, coordinating, and directing CMC Quality Assurance programs to assure GMP regulatory compliance in the development of Vor’s products. Role will plan and direct resources and activities to provide CMC quality assurance oversight and support of R&D and manufacturing operations. CMC support will include both internal and external manufacturing oversight. The candidate will work collaboratively with department managers, directors, and VPs to support corporate strategic objectives.
Key areas of responsibilities:
Support programs teams by assisting to define and implement the overall CMC lifecycle strategy, bringing the quality and compliance perspective to overall plans
Coordinate with program teams to ensure successful planning, execution, and delivery of projects associated with each program
Oversee batch record review and disposition, and oversee resolution of quality assurance activities, including deviations, OOS and OOT investigations, CAPAs and change controls
Mentor staff to provide appropriate quality decisions and feedback on various program activities and strategies
Organize and manage QA CMC employee training programs, including specific GxP training, maintain training records, and initiate training sessions
Manage, lead, improve and develop GMP QA CMC procedures and strategies per cGMP compliance
Provide key inputs toward the development of corporate quality policies, systems, and procedures
Develop and write quality assurance department standard operating procedures (SOPs)
Review and approve SOPs assuring consistency of policies and practices across technical disciplines
Lead and/or participate in risk assessments, review and approve risk reports
Participate in the review and approval of critical documentation such as analytical methods, specifications, reports, and protocols, including comparability and compatibility
Prepare and approve quality agreements with vendors and Contract Manufacturing Organizations (CMOs)
Perform vendor audits to ensure compliance with current regulations and practices
Participate in the review and approval of qualification and validation activities
Ensure high-quality content, accuracy, and integrity of regulatory submission documents in the eCTD format as necessary
Ensure Vor complies with all relevant regulations and guidelines
Skills and requirements:
BSc, MSc, PhD or equivalent life sciences degree with a minimum of 10 years pharmaceutical industry experience including 5 years in Quality Assurance
Experience with cell and gene therapy products preferred
Extensive knowledge of cGMP and ICH requirements for pharmaceutical development and manufacturing, including technical knowledge of analytical and standard compendial physical, chemical, and microbiological methods
Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities
Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions
Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
Open, available, transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
Experience in managing relationships with internal departments, external vendors, and partners in a collaborative, constructive manner
Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively,
Proficiency with MS Office, MS Project, PowerPoint, and eCTD format
Estimated 10% travel required
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The Associate Director/Director, CMC Quality Assurance will be responsible to act as a key QA CMC lead on program team(s). Candidate will be responsible for planning, coordinating, and directing CMC Quality Assurance programs to assure GMP regulatory compliance in the development of Vor’s products. Role will plan and direct resources and activities to provide CMC quality assurance oversight and support of R&D and manufacturing operations. CMC support will include both internal and external manufacturing oversight. The candidate will work collaboratively with department managers, directors, and VPs to support corporate strategic objectives.
Key areas of responsibilities:
Support programs teams by assisting to define and implement the overall CMC lifecycle strategy, bringing the quality and compliance perspective to overall plans
Coordinate with program teams to ensure successful planning, execution, and delivery of projects associated with each program
Oversee batch record review and disposition, and oversee resolution of quality assurance activities, including deviations, OOS and OOT investigations, CAPAs and change controls
Mentor staff to provide appropriate quality decisions and feedback on various program activities and strategies
Organize and manage QA CMC employee training programs, including specific GxP training, maintain training records, and initiate training sessions
Manage, lead, improve and develop GMP QA CMC procedures and strategies per cGMP compliance
Provide key inputs toward the development of corporate quality policies, systems, and procedures
Develop and write quality assurance department standard operating procedures (SOPs)
Review and approve SOPs assuring consistency of policies and practices across technical disciplines
Lead and/or participate in risk assessments, review and approve risk reports
Participate in the review and approval of critical documentation such as analytical methods, specifications, reports, and protocols, including comparability and compatibility
Prepare and approve quality agreements with vendors and Contract Manufacturing Organizations (CMOs)
Perform vendor audits to ensure compliance with current regulations and practices
Participate in the review and approval of qualification and validation activities
Ensure high-quality content, accuracy, and integrity of regulatory submission documents in the eCTD format as necessary
Ensure Vor complies with all relevant regulations and guidelines
Skills and requirements:
BSc, MSc, PhD or equivalent life sciences degree with a minimum of 10 years pharmaceutical industry experience including 5 years in Quality Assurance
Experience with cell and gene therapy products preferred
Extensive knowledge of cGMP and ICH requirements for pharmaceutical development and manufacturing, including technical knowledge of analytical and standard compendial physical, chemical, and microbiological methods
Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities
Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions
Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
Open, available, transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
Experience in managing relationships with internal departments, external vendors, and partners in a collaborative, constructive manner
Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively,
Proficiency with MS Office, MS Project, PowerPoint, and eCTD format
Estimated 10% travel required
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