Director CMC Quality Compliance (Hybrid)

Job Description General Summary The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. This position provides technical and strategic leadership for inspection readiness and compliance including processes and associated governance across all GMP areas. This position focuses not just on the “what” but the “how”, ensuring phase appropriate and risk-based compliance. Key Duties and Responsibilities Accountable for inspection readiness, inspection management, and compliance programs across all GMP areas including external CMOs and internal manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory space and incorporate into phase appropriate control strategies. Responsible for overseeing internal and external sites, working with cross-functional teams to identify areas of compliance risk, and implementing action plans to improve the overall compliance and quality culture of the sites. Monitors health of the inspection readiness and management system, ensures appropriate escalations, and reports to leadership through established governance structure. Works across quality and functional areas to ensure inspection program is scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations. Provides technical and strategic support to all areas including other quality groups for compliance and inspection related decisions. As a people manager within the organization, provides leadership, development and coaching to staff. Provides enterprise-level thinking and strategy direction to staff and acts as a change agent for improvements. Knowledge and Skills Expert knowledge of global GMP requirements and experience across multiple GxP areas. Highly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership. Ability to evaluate quality matters and make decisions utilizing risk-based approach. Strong technical knowledge including but not limited to: GMP regulations, inspection management, risk management, and quality governance. Solid quality culture knowledge and understanding of how to influence and improve overall compliance. Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams. Education and Experience Bachelor's degree in a scientific or allied health field (or equivalent degree). Typically requires 10 years of work experience and 3 years of management experience, or the equivalent combination of education and experience. Other: 5-10% Travel may be required. Pay Range $184,600 - $277,000 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: Hybrid: work remotely up to two days per week; 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 View email address on click.appcast.io. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. 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. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , 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. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)