Senior Manager - Clinical Analytical Quality Assurance 910 (Contract)

Job Description

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager provides end-to-end QA oversight of contract analytical laboratories supporting clinical and commercial biologics and combination product programs. Take ownership of vendor meetings with analytical laboratories to enhance oversight of vendor performance, drive timely investigation closure, and ensure alignment with Vertex’s quality and compliance standards.

 

Key Duties and Responsibilities:

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Participates in cross-functional teams as an experienced Quality technical resource
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• 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 and product impact assessments for investigations resulting from deviations and OOS.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Identify, facilitate, and/or lead continuous improvement efforts
• Maintains Quality Metrics to support process improvement activities
• Provides tactics to address compliance gaps or determines enhancements to cross-functional quality systems
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Manages audit CAPAs & metrics
• Provides technical advice for partner and regulatory agency audits

 

Knowledge and Skills:

• 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
• 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
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a a variety of information; able to work outside of precedent and takes a new perspective on existing solutions
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Strong experience with electronic document management systems (e.g., Veeva)

 

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 6 years of experience, or the equivalent combination of education and experience
• Experience in early Phase to Phase 3 Analytical Quality preferred

Contract Length: 12 months, with the possibility of an extension

Pay Range

$85/hr.-$90/hr.

Shift/Hours

Hybrid

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

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No C2C or Third-Party Vendors