Associate Director, CMC Quality Compliance and Inspection Readiness

Regulatory Jobs; Boston (MA); Hybrid; USD 148,000 - 221,000; Full time

Job summary

Vertex is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to lead inspection readiness programs across external sites, drive continuous improvement, and partner across functions to sustain regulatory compliance and a strong quality culture.

The role requires a bachelor’s degree in a scientific discipline and 8+ years of relevant experience, with up to 20% travel; hybrid-eligible or on-site options are available.

Qualifications

• Knowledge of regulatory requirements and inspection expectations globally.
• Experience in multiple modalities preferred.
• Strong technical knowledge including 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.

Responsibilities

• Responsible for inspection readiness and compliance programs for external operations.
• 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.
• Drive optimization, continuous improvement, and operational excellence to enhance processes.
• Report inspection readiness status including risks to leadership and governance forums

Skills

Regulatory knowledge

Cross-functional collaboration

Inspection management

Risk management

Continuous improvement

Facilitation / coaching

Performance indicators analysis

Education

Bachelor's degree in a scientific discipline

8+ years of relevant experience

Job description

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; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

$147,500 - $221,300

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.

#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 [e-mail]