Director, Commercial Quality Control (CQC)
Vertex Pharmaceuticals
This is a Full-time position in Boston, MA posted November 7, 2021.
Director, Commercial Quality Control (CQC)
The Director, Technical Operations Analytical/QC has central responsibility for management of the Commercial Quality Control (CQC) Lab, including lab operations, coordination of testing, data review, equipment/software qualification, commercial reference standards management, stability data management/trending, and compliance with cGMP’s.
The Director is responsible for overseeing activities of staff, adapting personnel deployment to changing priorities, partnering with cross-functional teams, and leading the QC organization in compliance and efficiency, in order to provide first-in-class service to external and internal customers.
The Director champions continuous improvement of processes and systems within Vertex and leads implementation efforts in the forefront of GMP compliance and the changing regulatory landscape.
The Director is a key member of the Technical Operations Analytical team, takes a leadership role in company-wide initiatives, and guides resolution of critical issues impacting manufacturing and analytical operations.
KEY RESPONSIBILITIES:
- Oversee all Commercial QC operations to ensure laboratory activities are scheduled and prioritized to meet
- commitments on-time
- Leads collaborations with Pharmaceutical Development, GIS, Quality Assurance, EH&S and other functional areas to develop / implement Laboratory Controls that ensure compliance with current global regulations, while building efficiency and flexibility in laboratory operations
- Represents QC function to help lead implementation or improvement of enterprise systems in use within QC lab, such as LIMS, data historian, ELN, other automated systems or the QMS
- Sets strategic direction by helping to establish department goals which are aligned with company goals
- Ensure all lab personnel have adequate training, education, and experience to perform their GMP related job function effectively
- Lead interactions with regulatory inspectors during audits
- Provide technical / compliance input to analytical technical functions (e.g.
method validation/transfer, reference standards, etc.)
- Develop relationships with strategic external partners in support of Vertex’s expanding commercial portfolio
- Assess staffing needs and maximize productivity
- Provide developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develops, and retains personnel
- Authoring, reviewing, and approving technical documentation, including reports, protocols, work instructions, SOPs, etc.
- Ensure positive and effective relationships between Vertex and key suppliers of materials, technology, and manufacturing and testing resources
REQUIRED EDUCATION LEVEL AND EXPERIENCE
- Bachelor’s Degree in science or related discipline is required.
- Typically requires 12 years of experience in pharmaceutical/biopharmaceutical industry with 8 years of increasing management responsibility, or the equivalent combination of education and experience
REQUIRED KNOWLEDGE AND SKILLS
- Proven ability to oversee and lead a complex operation, including facility and staff
- Extensive knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections
- Experience working in a commercial manufacturing operation in the capacity of QC with GMP experience
- Proven experience in managing a high-performance team
- Demonstrated abilities to hire, train and coach analytical laboratory staff as well as lead and develop QC management
- Demonstrated knowledge and experience in several of the following: OOS/OOT
- investigations, method validations, stability studies, LIMS, raw material testing, HPLC, dissolution, GC,
- Karl Fischer, IR, solid dosage form manufacturing, QA interactions, analytical development, instrument and facility qualifications, regulatory inspections, regulatory submissions
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and efficiency
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 ApplicationAssistance@vrtx.com.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.
The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF.
Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease.
Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London, UK.
Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America.
Vertex is consistently recognized as one of the industry’s top places to work, including nine consecutive years on Science magazine’s Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.
For company updates and to learn more about Vertex’s history of innovation visit or follow us on Facebook , Twitter , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.
By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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