Quality Tech Transfer and Process Validation Manager

General position summary:

The Quality Manager is an advanced technical resource in the principles and application of Quality Assurance and compliance, specifically in process validation and technical transfers. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

This is a Hybrid role based out of the Boston office.

This position reports directly to the Associate Director of GMP Operational Quality.

Key Responsibilities:

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

• Participates in cross-functional teams as aQuality technical resourceresponsible for providing quality oversight and support to Validation and Tech Transfer manufacturing operations within Vertex or at contracted suppliers

• Contributes to the Validation strategy for new products and second sources to ensure compliance to regulations and risk mitigation strategies

• Conducts Validation and Tech Transfer GMP document reviews including Master Validation Plans, Protocols, and Reports

• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls

• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis, product and process validation impact assessments for investigations resulting from deviations and OOS.

• Ensures product knowledge transfer to the Quality Operations team

• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed

• Supports the onboarding of Qualified vendors through the establishing of Quality Operations oversight.

• Participates in Preapproval Inspection Readiness activities by collaborating with the Compliance team and contracted suppliers

• Identifies and communicates risks and assist with risk mitigation plans as necessary

• Contributes to the creation and review of Inspection Storyboards

• Assists in review of audit responses and CAPA closures

• Provides technical advice for regulatory agency audits

• Identify, facilitate, and/or lead continuous improvement efforts

• Maintains Quality Metrics to support process improvement activities

Minimum qualifications:

• Experience providing Quality support and oversight of GMP manufacturing operations for validations and tech transfers

• Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting

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

• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives

• 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

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

• 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

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

• Strong experience with electronic document management systems

• Ability to travel domestically and internationally up to 20%.

Education and Experience:

• Bachelor's degree in a scientific or allied health field with 5+ years of relevant work experience, or the equivalent combination of education and experience.

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