Sr. Quality Operations Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Key Leadership Skills
· Cross- functional collaborator
· Results Driver
Key Knowledge/ Skills and Competencies
· 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
· 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
· As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to 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 client, 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:
· 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.
Pay Rate Range: 60-64/hr
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