GMP Operational Quality Packaging & Labeling Validation Associate Director

Job Description

The Associate Director of GMP Operational Quality Assurance is an advanced technical resource and 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. The Associate Director of Quality Assurance is responsible for oversight of multiple Validation projects associated with Product Launch and Continuous Improvements, ensuring effective alignment with business timelines and compliance with relevant global regulatory requirements. This role is expected to work closely with business partners and stakeholders to ensure successful project execution for Finished Goods (FG) commercialized globally. The role is responsible for coordinating and/or or executing Validation activities on multiple complex projects and ensures process robustness from initial design through ongoing product supply and continuous improvements. This position reports directly to the Director of GMP Operational Quality.

Key Responsibilities:

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

• Responsible for FG Validation of commercial products in all global regions for the GMP Operational Quality organization.
  • Standardize Validation processes to ensure compliance and consistency across programs.
  • Manage Validation commercialization oversight for operating teams through technical transfer, validation, MBR creation, launch support and process improvements through product/process life-cycle management.
  • Partner with internal Vertex operational stakeholders to establish primary/secondary packaging Validation ‘best practices’ to support growing business and complexities.
• Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
  • Support Quality Escalation Lead (QEL), Escalation Action Committee (EAC) and Material Review Board (MRB) discussion, as required.
• Support lifecycle management major events and/or changes for finished goods GMP operations
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy
• Establish Quality-by-Design (QbD) principles for primary, secondary and FG Packaging and Labeling.
  • Provide strategic quality oversight to operations at external manufacturing sites in alignment with the Vertex corporate Quality strategy
  • Develop framework for ongoing QbD efforts
  • Establish Critical Process Parameters (CPPs) for relevant manufacturing process.
  • Establish Continuous Process Verification (CPV) measures to evaluate manufacturing process health.
  • Create KPIs and Metrics to evaluate Validation process analytical data to emphasize process reliability and effectiveness.
  • Oversee OOS, OOT and Trending for primary, secondary and FG manufacturing operations.
• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions and reduce risk of potential supply disruptions.
• Establishment of Quality Processes/Process Ownership –for FG Quality Management System of Global Commercial Finished Goods
  • Define and optimize Validation work process
  • Serve as training owner and SME for their process
  • Serve as document owner for cross-GxP process
  • Serve as review/approver or owner of deviations
  • Monitor and trend events and identifies/proposes corrective actions
  • May serve as CAPA owner
  • Identify risks and communicate gaps to Quality System owner
• Establish Continuous Improvement framework for Validation and continued  Commercial Product Launches for all global regions; Lead or participate in process improvement initiatives   
• Serve as SME Responder or assist in providing front / back-room inspection support; Assists in preparation of audit responses

Minimum qualifications:

Master’s degree and 5-8 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Experience providing Quality support and oversight of GMP manufacturing operation at Contract Manufacturing Organizations and Contract Test Laboratories including batch release preferred; Previous experience and success navigating gray areas and compliantly leading cross functional teams through complex issues; Ability to negotiate and collaborate with team members to achieve results
• In depth knowledge of cGMP and GDP requirements governing oral drug product manufacturing practices  
• Experience with primary and secondary packaging (oral solid dosage forms preferred) development and operations with proficient knowledge in a pharmaceutical setting.
• Experience in Facilitation/ Problem Solving /Organization/Coordination and planning/Project Management etc./Root Cause Analysis tools/methodology/technical writing
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
• Experience in conducting / hosting / participating in regulatory / vendor or internal audits
• Project Management / Continuous Improvement

• In-depth experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

• Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
  • Demonstrated ability to work independently to provide QA support for large, multifaceted projects

• Collaboration / Teamwork / Conflict Management
  • Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action
  • Ability to independently lead cross-functional teams and represent the Operational Quality unit
  • Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
• Critical Thinking / Problem Solving: Demonstrated adaptability, thinking analytically with ability to conduct data analysis while paying attention to details
• Knowledge of applications:
  • Esko-Artwork Management System
  • OPM (Oracle)
  • MS Office
  • PowerBI
  • Veeva

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:

$159,800 - $239,800

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.

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 [email protected]