Job Description
The site Quality Operations Associate Director oversees the operational execution at Cell & Gene Manufacturing site of the quality system processes such as documentation, training, and vendor in alignment with the global Vertex processes.
The role will act as the liaison between various cross-functional partners within Vertex Cell and Genetic Therapies (VCGT) to coordinate compliant executing and within the global quality systems.
This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210, 5 days on site (M_F).
Key Duties & Responsibilities
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Contributes to the advancement and compliance of the site documentation and training programs by identifying opportunities and supporting risk-appropriate enhancements in line with the Global Quality systems.
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Management of the documentation process including reconciliation of batch records, logbooks, and other GMP documentation.
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Partner with internal manufacturing t Implement, develop and lead the monitoring of key quality system tiered metrics and risks to ensure the site operational execution is in a state of control.
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Coordinates and oversees training activities together with the internal manufacturing coordinator within a GxP environment
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Work with global quality and functional areas to ensure program is aligned to Vertex standards while also being scalable and flexible
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Participate with stakeholder on operational vendor related issues impacting the site manufactured product. Oversees risk based and phase appropriate resolution.
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Monitors performance of vendors through operational feedback contributing operational input to the Global Vendor process as well as addressing SCARs, and other inputs. Ensures escalation and compliant governance.
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As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff
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Ownership of the Document Control Room at LC1 including cleanliness, organization, supply inventory, and room access. Gather stakeholder feedback to improve and gain efficiencies
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Act as the operational site quality system SME for QS and strategic support to functional areas.
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Clearly communicate program and status updates to managers, leadership, the Quality team, and stakeholders
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Responsible for proper archiving of GMP documentation, including scanning and storage to Fan Pier
Required Education Level
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Bachelor's degree in an engineering/scientific discipline, or a related field
Required Experience
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+8 years of relevant experience or the equivalent combination of education and experience
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Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
Required Knowledge/Skills
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Knowledge of global GMP requirements governing CGT products
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Ability to evaluate quality matters and make decisions utilizing risk-based approach
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Strong technical knowledge including but not limited to: training, document control, and quality governance
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Solid quality culture knowledge and understanding of how to influence and improve overall compliance
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Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
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Experience across multiple GxP areas
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Proven ability to identify and analyze performance indicators
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Strong leadership skills with the ability to thrive in a high throughput environment with competing priorities
Other Requirements
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Ability to lead and manage projects/teams within corporate objectives and project timelines
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Successful in mentoring people managers
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Collaboration / Teamwork / Conflict Management
In this On-Site designated role, you will 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.
Pay Range:
$152,200 - $228,300
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
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]
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What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
