GMP Operational Quality Senior Specialist

Job Description

Position Summary

The Quality Operations Sr. Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. Quality Operations Sr. Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition.

• This role reports to the first shift Sr. Manager, GMP Quality - Cell & Gene
• This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210
• This role is 1st shift 7:00am-5:30pm Sunday to Wednesday

Key Duties & Responsibilities

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex 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 Vertex, 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 Level

• 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.

Required Experience

• 2-5 years of relevant work experience minimum

Required Knowledge/Skills

• 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
• Knowledge in the following areas:
• 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
• Expert knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; expert knowledge of global GMP requirements and managing quality in support GMP manufacturing
• Demonstrated success in building high-performing teams and skilled at managing team and individual development
• Highly effective management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
• Expertly lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
• Substantial skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action; negotiation skills may be required
• Demonstrated ability to evaluate unusually complex quality or multi-disciplinary matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
• Extensive experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
• Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Other Requirements
Indicate required certifications, licenses, or specialized trainings.

•  N/A

Pay Range:

$35.00 - $53.00 USD/hour

Pay Range:

$0 - $0

Disclosure Statement:

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as: 
1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 
2.    Hybrid: work remotely up to two days per week; or select
3.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]