Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)

Job Description General Summary: The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. Key Duties and Responsibilities: Responsible for inspection readiness and compliance programs for external operations. Works cross-functionally and cross-company to ensure sites achieve and maintain a state of inspection readiness. Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends. Support and oversee inspection execution including responses and closure of CAPAs. Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing. Develop trusted partnerships with external sites. Drive optimization, continuous improvement, and operational excellence to enhance processes. Report inspection readiness status including risks to leadership and governance forums. Knowledge and Skills: Knowledge of regulatory requirements and inspection expectations globally. Experience in multiple modalities preferred. Strong technical knowledge including but not limited to: inspection management and risk management. Continuous improvement experience such as six sigma or lean. Proven ability to lead improvement projects and project teams and organize various teams and forums. Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams. Proven ability to identify and analyze performance indicators. Education and Experience: Bachelor's degree in a scientific discipline, or allied health field or equivalent degree. 8+ years of relevant experience. Travel requirement: up to 10-20% including international travel possible. Hybrid-Eligible Roles: 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. #LI-Hybrid #LI-AR1 Pay Range: $147,500 - $221,300 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. Benefits: Medical, dental and vision benefits Generous paid time off (including a week-long company shutdown in the Summer and the Winter) Educational assistance programs including student loan repayment 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. #LI-Hybrid 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)