Sr. Quality Operations Specialist, Gene Therapy (v549)

Lenox Executive Search is seeking a candidate for a contract role for a Sr. Quality Operations Specialist, with one of our global pharmaceutical clients. This is a one year contract position with the possibility of extension/conversion.

Key Knowledge/ Skills and Competencies of a Sr. Quality Operations Specialist:

• Strong leadership skills with the ability to thrive in a high throughput environment
• Collaboration / Teamwork
• Ability to independently lead cross-functional teams and represent the Quality unit
• Communication
• Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Attention to detail
• Expert knowledge of GMP requirements governing oral drug products manufacturing practices
• Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP manufacturing

KEY RESPONSIBILITIES of a Sr. Quality Operations Specialist:

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Company Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operations
• Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Responsible for review and approval of COAs, and product release
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of manufacturing documents.
• Develop and deliver technical training programs
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Company, as needed
• Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
• Provides experienced technical advice for fill finish related program decisions
• Provides project support involving technical transfers, engineering projects and similar activities
• Participate in compliance walkthroughs and help drive the closure of any observations
• Responsible for identifying risks and communicating gaps for GMP process/systems
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities
• Participate in process improvement initiatives (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
• Experience on product complaints investigations and recalls

REQUIRED EDUCATION AND EXPERIENCE of a Sr. Quality Operations Specialist:

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including batch release
• Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting
• Cell and gene therapy cGMP’s and associated CMC regulatory considerations
• Aseptic processing
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise
• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.