Associate Director, GMP Operational Quality Cell and Gene (On-site)

Job Description

General Summary :

The Associate Director, Operational Quality Cell and Gene is recognized as an expert internally in the principles and application of quality assu rance and compliance .

The Operational Quality Associate Director Cell and Gene coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects.

The Operational Quality Associate Director adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

KEY RESPONSIBILITIES :

As part of the Quality Operations group primarily responsible with providing quality oversight and support to operations at the Vertex CPI and Drug Product Facility in the following key areas / activities, support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.

In process and Drug Product Release

Accountable and Responsible for the clinical batch disposition . Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.

Accountable and responsible for approval of CPI and Drug product clinical lot

Accountable and responsible for archival of batch records and other supporting documents in Veeva QMS

Responsible for monitoring and tracking performance metrics, trends; including site metrics for disposition

Compliance Oversight of Internal Operations - QA Operations and Compliance

Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including packaging and shipment.

Review and approval of Manufacturing documents e.g. MBR, AP S s etc.

Provide QA support of development change controls, GMP investigations , associated CAPAs and Effectiveness Checks .

Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.

Responsible for identifying risks and communicating gaps for GMP p rocess / systems.

People and Performance Management

Responsible for the following activities

Talent Acquisition / Recruiting / Interviewing / Selection / Onboarding

Performance Management (goals, monitoring, reviews)

Monitoring / Supporting Employee Engagement and Retention

Succession Planning

Accountable to provide oversight of day to day operations

REQUIRED KNOWLEDGE, SKILLS , AND COMPETENCIES

Key Leadership Skills :

Cross- functional collaborator

Results Driver

Key Knowledge / Skills and Competencies :

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

Project Management / Continuous Improvement

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

Proficiency utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

Collaboration / Teamwork / Conflict Management

Ability to independently lead cross-functional teams and represent the Quality unit

Communication / Coaching / Influencing

Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff

Ability to effectively influence others within technical area of expertise

Ability to communicate effectively across all organizational levels

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 VCGT drug products and knowledge of VCGT manufacturing practices

Proven experience supporting GMP manufacturing either via experience in manufacturing and / or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role

Demonstrated ability to work independently to provide QA support

REQUIRED EDUCATION AND EXPERIENCE :

Demonstrated success independently lead ing cross-functional teams

Experience providing QA support and oversight of GMP manufacturing operation including batch release

Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA

M.S (or equivalent degree) and 2-3 years of relevant work experience, or

B.S in scientific or allied health field (or equivalent degree) and 7 +years of relevant work experience

On-Site designated role, you will work five days per week on-site with ad hoc flexibility.