Director, GMP Operational Quality (Onsite, Sun-Wed)

Job Description

The Director, Quality Assurance GMP Operations will have responsibility for quality oversight of the manufacturing process and operations for internal manufacturing across operational shifts.   Responsibilities include day-to day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches.

• The role will closely partner with operational stakeholders and cross functional leaders to lead/support the manufacturing operations and maintain quality oversight of the process. 
• Responsibility includes ensuring all shift quality operational activities are completed, and execution of quality & technical risk identification and mitigation, participation in governance committees and improvements to the disposition process. 
• A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities. 

• This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. The working hours are Sunday to Wednesday, working hours are 8.00am to 6.00 pm. This role will supervise the QA operations shifts in Leiden Center:  1st shift 7:00am-5:30pm and 2nd shift 12:30pm-11:00pm.

Key Duties & Responsibilities

• Directs multiple teams responsible for internal commercial operations in support of GMP manufacturing and testing activities, including disposition of intermediates, working cell banks and clinical and commercial drug product internally at Vertex manufacturing facilities.
• Responsible for clinical and commercial batch release, for Us and ex US markets including liaising with QP certification and importation requirements where applicable.
• Monitors operational activities and assesses for continuous improvement within the QA operations. 
• Proactively identify trends/gaps/risks and implement plan to mitigate such trends/gaps and risks.
•  Prepare metrics and participate in Business /Functional Review Meetings to ensure Quality issues are raised and addressed, as necessary
• Provide guidance and support to in-country Quality responsible person requests in relevant geographies
•  Leads Material Review Board (MRB) discussions, as necessary
• Ensures quality staff assesses and approves change controls for commercial processes for assessment of lot disposition process. 
• Leads and manages highly complex projects/teams within corporate objectives and project timelines
• Participates in cross-functional projects in Quality Assurance operations role
• Provide support/lead or assist with preparing for and hosting partner audits and regulatory agency inspections.
• Collaborates with in house Quality counterparts
• Responsible for team goal setting in best pursuit of corporate and department goals
• Mentors to staff on quality and technical related areas
• Responsible for team development

Required Education Level

• Bachelor's degree in a scientific or allied health field
• Master's degree is preferred

Required Experience

• Typically requires 10 years plus of work experience and 3 years of management experience, or the equivalent combination of education and experience

Required Knowledge/Skills

• 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)

#LI-Onsite #AR-1

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    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]