Senior Quality Manager, Labeling and Artwork

Job Description

VERTEX PHARMACEUTICALS

Quality Assurance

POSITION DESCRIPTION

GENERAL POSITION SUMMARY:

The Senior Quality Manager is recognized as an expert in the principles and application of quality and regulatory compliance. The Quality Manager is responsible for managing global labeling and artwork of commercial finished products for the small molecule division of Vertex. The incumbent is responsible for overseeing labeling and artwork processes from development / submission through approval and life-cycle management changes. The position manages multiple projects simultaneously ensuring alignment with business timelines, corporate goals, and compliance. This role works closely with business partners and stakeholders to ensure compliance of finished packaging adheres to local compliance requirement across all strategic production facilities.

Key Responsibilities:

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

• Maintain process quality oversight for labeling and artwork management of commercial printed components.
• Establish training program for Operational Quality personnel to support global commercial product supply through launch and life-cycle management changes.
• Develop key performance and quality metrics regarding Labeling and Artwork Management. Collect and analyze data to improve performance.
• Coordinate lifecycle management changes with key external contract partners responsible for labeling, printing, packaging, and distribution.
• Oversee Label implementation across all global regions for Vertex and contracted third parties.
• 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
• Provide quality support for planning of product launches and tracking of new artworks
• Provide compliance guidance to Commercial project teams on Label and Artwork review.
• Establishment of Quality Processes/Process Ownership - Labeling and Artwork of Commercial Finished Goods
  • Define and optimize 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
  • Oversee generation of process related metrics/monitors for efficiency
• Support deployment of the Quality Management System as GMP Representative:
  • Oversee Vertex Artwork Management Process (VAMP) integration with new digital systems including ESKO for Artwork Management
  • Conduct ongoing monitoring of regulations and Participate in update of Quality Systems Policy statements
  • Coordinate, Facilitate and Follow-up for Quality Leadership Team
  • Communicate Gaps/risks
  • May participate on process improvement initiatives
  • Review Risk Profile and Performance updates for presentation to Quality Leadership Teams as needed
  • Review GMP Impacted Procedures
  • Collect and analyze Metrics
• Provide Audit / Inspection Support:
  • Serve as SME Responder
  • Conduct preparation activities
  • Provide both front & back room inspection support
  • Support Post inspection activities

Minimum qualifications:

Bachelor's degree in a scientific or allied health field (or equivalent degree) and 6+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Strong leadership skills with the ability to thrive in a high throughput environment

• Project Management / Continuous Improvement

• Ability to lead and manage projects/teams within corporate objectives and project timelines

• 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 independently lead cross-functional teams and represent the Quality unit
  • Ability to understand and translate business needs
  • Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
  • Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills
• Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk based approach
• Flexibility/Adaptability
• Attention to detail
• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology
  • Audit process
• Broad GxP Knowledge and understanding across lifecycle of the product
• Sense of urgency- ability to act quickly/escalation process/transparency
• Ability to:
  • Drive results on time every time
  • Maintain composure under pressure
  • Take ownership and accountability for shared information
  • Understand and translate customer needs
• Knowledge of applications:
  • Veeva
  • ESKO
  • OPM (Oracle)
  • QDoCCs
  • MS Office

Flex Designation:

Flex Eligibility Status:

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