Associate Director, GMP Operational Quality

Job Description

General summary:

The Associate Director is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Stability and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel to support department and functional activities.

Key Duties and Responsibilities:

The responsibilities of this role may include, but are not limited to, the following:

• Leads QA oversight of commercial stability program. Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions in support of QA Analytical function.
• Guides and conducts quality investigations, OOS/OOT investigations, deviations. Communicate any risks and gaps to management as known.
• Reviews investigation reports and corrective action plans for adequacy and compliance. This includes escalation assessment, root cause analysis and product impact assessments for investigations resulting from deviations and OOS. May serve as an Escalation Lead.
• Ensures appropriate CAPA actions are identified/evaluated and approves investigations/CAPA plans/actions.
• Assesses and approves Change Controls.
• Generates and analyses Laboratory Control and Stability Metrics for QLT's and QMR's. Provides support to Laboratory Control PON.
• Reviews and approves Stability Studies, Stability Protocols, analytical data, and maintains internal stability data trackers. Supports regulatory filing reporting and inquiries as needed.
• Provides oversight to the stability trending program. Reviews and approves stability trend reports in a timely manner. Identifies and discusses stability trends with management
• Provides support to QA management with process improvement activities. Identifies and facilitates continuous improvement efforts and leads continuous improvement projects as assigned.
• Provides tactics to address compliance gaps or determines enhancements to cross-functional quality systems.
• Conducts review of procedures, work instructions, specifications, stability protocols.
• Provides back-up support for other commercial projects when needed. Assists with internal audits and external regulatory agency inspections when needed.
• Responsible for the following activities related to people management responsibilities.
  • Talent Development and Coaching
  • Performance Management (goals, monitoring, reviews)
  • Monitoring /Supporting Employee Engagement
  • Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs
  • Accountable to provide oversight of day-to-day operations
  • Assists with workforce planning/resource modeling

Preferred Qualifications:

• Broad GxP Knowledge across Product lifecycle. In-depth knowledge of global GMP stability requirements.
• Ability to think critically and strategically with clear goals in mind.
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; ability to work outside of precedent and takes a new perspective on existing solutions.
• Ability to communicate cross-functionally to a wide variety of audiences, question stakeholders to understand their needs.
• Successful track record influencing cross functional teams and gain alignment on proposed actions
• Strong experience in leading Quality Events investigations, Root Cause Analysis (RCA), and CAPA implementation.
• Demonstrated ability to independently lead cross-functional teams and to provide QA advice for large, multifaceted projects.
• Strong laboratory/QC experience and understanding of various analytical techniques.
• Demonstrated ability to manage teams and to develop personnel. Demonstrated ability to mentor and guide staff and transfer technical knowledge and teaching quality management skills.
• Ability to effectively organize and plan activities.
• Experience in Presentations and Risk Management.
• Operational QA experience in analytical or manufacturing setting is desired.

Education and Experience:

• Master's degree and 5-8 years of work experience in a scientific or allied health field, or Bachelor's degree in a scientific or allied health field and 10+ years of relevant work experience, or relevant comparable background

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 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 ApplicationAssistance@vrtx.com