Job Summary

The Director, Regulatory Affairs and Quality Assurance is responsible for ensuring the business maintains compliance with the following:  Quality Systems, cGMP and cGTP models, Institutional Review Board determinations and all applicable Federal, State, Local, International, and Industry regulations and standards.  

Essential Responsibilities

•    Responsible for monitoring compliance with all applicable regulations (Local, State, Federal, International, FDA, AABB, OSHA and other applicable agencies).  
•    Provide guidance and mentor direct reports to grow the QA/RA department.
•    Review SOPs and policies to ensure compliance with applicable regulatory requirements to assure that products have the safety, quality, identity, purity, and strength that they purport to possess.
•    Develop, operate, and maintain the effectiveness of the Quality Management System, the processes/procedures; Document Control, Deviations, Change Control, CAPA, Internal/customer Auditing, lot release & Quality Management Review.
•    Review and provide guidance to validation/revalidation reports (IQ, OQ, PQ).
•    Responsible for monitoring the training program for the site.
•    Verify all activities related to human subject research are conducted in accordance with IRB determinations and approvals. Ensure data for the quarterly management review is generated for all departments and distributed to all attendees prior to the meeting.  
•    Conduct internal and external audits and report results to executive management.
•    Coordinate and manage Supplier Qualification processes and communicate outcome to Management. 
•    Lead Process Improvement activities within the QA/RA department or across other departments to streamline and improve existing processes to eliminate non-value added activities.
•    Evaluate and approve employee training and competency programs to ensure compliance with all regulatory requirements.
•    Communicate all quality related issues and trends to executive management and provide periodic reports on regulatory and quality assurance matters.
•    Support regulatory inspections and draft/coordinate responses (if required) to ensure the site is compliant with regulatory requirements. 
•    Maintain the approved supplier list and ensure all materials received and services performed are from approved suppliers and conform to specifications.
•    Ensure all required licenses, permits, registrations and accreditations are up to date.
•    Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance and notify applicable department(s) of regulatory changes.
•    Quality system reports oversight including deviations, complaint, exceptions, MRBs, etc. Monitors compliance and generates statistics for tracking and trending purposes. Assist in the development of Corrective Actions and Preventative Actions.
•    Perform risk analysis to evaluate risks based on scientific data, experience, or documentation to ensure limited risk to the product and patient.
 

Job Qualifications

•    10+ years of relevant GxP experience either in biotech/pharmaceutical industry, Cell and Gene Therapy with at least 5+ years in Quality Leadership including management of direct reports.
•    5+ years management experience leading matrix, global teams required.
•    BA/BS degree in life sciences.  Advance degree is highly preferred. 
•    Process improvement/Lean Six Sigma/Agile methodology experience preferred.
•    Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.
•    5+ years of hosting or leading regulatory inspections and preparing staff for regulatory inspections
•    Strong working knowledge of global GMP/GLP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct
•    Experience in IT and software validation.
•    Experience with FDA and EMA requirements related to cleanrooms and sterile manufacturing required.
•    Ability to work effectively with cross-functional teams.
•    Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
•    Demonstrated ability in setting successful quality strategies and building and leading the function
•    Proven track record in establishing a quality organization and managing GxP Quality staff.
•    Demonstrate excellence in all communication and interpersonal skills. Able to develop and maintain cooperative working relationships with other staff members, management, physicians, and customers.
•    Ability to travel 15% domestically and/or internationally. 
 

Compensation Data

The pay range for this position is $169,700 – $209,600. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.