Senior Manager - Clinical Analytical Quality Assurance 910 (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 117,000 - 124,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a Sr. Quality Manager to provide end-to-end QA oversight of contract analytical labs supporting clinical and commercial biologics programs. The role involves vendor oversight, investigations, CAPA, and quality systems, with a hybrid work arrangement.

You will lead cross-functional teams, draft Quality Agreements, participate in audits, and drive continuous improvement while ensuring compliance with cGMPs.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 6 years of experience in analytical quality.
• Experience in early Phase to Phase 3 Analytical Quality preferred.
• In-depth knowledge of cGMPs and global GMP requirements.

Responsibilities

• Provide end-to-end QA oversight of contract laboratories supporting clinical and commercial programs.
• Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex.
• Assist Change Control owners with ensuring compliance to change procedures.
• Assess and approve change controls and CAPAs.
• Conduct quality investigations/deviations and root cause analyses.
• Maintain Quality Metrics and drive continuous improvement.
• Support internal and external audits and coordinate audit CAPAs.
• Provide QA advice for partner and regulatory agency audits.

Skills

QA oversight

Cross-functional leadership

Change control

Investigations

Root cause analysis

CAPA

GMP knowledge

Audits

Education

Bachelor's degree

Tools

Veeva

Job description

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

No C2C or Third-Party Vendors