Operational Area Quality Associate Director

Job Description

General Summary:

The Associate Director GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertexs external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls commercial supply continuity support for global jurisdictional expansion and highlevel combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams.

Key Duties and Responsibilities:

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions

• Oversee CMO/Vendor performance establishment of Quality Agreements and adherence of Quality Agreement terms

• Enable team to achieve team goals/objectives and enable their individual career development

• Develop and maintain compliant quality processes to support GMP activities

• Oversee the QA support of Change Controls GMP investigations and associated CAPAs.

• Performs review and approval of master and executed batch records to support drug substance (DS) drug product (DP) device (Autoinjector) and finished goods (FG) disposition activities

• Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes

• Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.

• Support review of regulatory submissions as applicable

• Lead continuous improvements of department processes realizing efficiency gains and ensuring team continues to meet expanding business needs with lean resources.

• Lead and follow up on any QLT action items assigned.

• Identify and communicate risks and assist with risk mitigation plans as necessary

• Supports internal audit or external audit programs; assists in preparation of audit responses

• Provide comprehensive knowledge support for partner and regulatory agency audits

• Assist management team in budgeting and scheduling

• Responsible for the following activities related to people management responsibilities:

• Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding

• Accountable to provide oversight of day to day team operations

Knowledge and Skills:

• In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing

• Demonstrated success in building high-performing teams and skilled at managing team and individual development

• Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality accuracy and timeliness

• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings assist with project planning and facilitate attainment of project objectives

• Ability to independently lead cross-functional teams and represent the interests strategies and objectives of Quality unit

• Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development

• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders customers or vendors to adopt of a new point of view and/or to take action

• Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions

• Substantial experience successfully leading event investigations Root Cause Analysis (RCA) and CAPA

• Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections

• Supstantial experience with electronic document management systems (e.g. Veeva)

Education and Experience:

• Bachelors degree in a scientific or allied health field (or equivalent degree)

• Typically requires 8 years of work experience and 2 years of management experience or the equivalent combination of education and experience

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Pay Range:

Disclosure Statement:

Flex Designation:

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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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 persons 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