GMP Operational Quality Senior Manager (Contract) 26342

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects with emphasis on QA GMP disposition of drug products and devices.

Key Duties and Responsibilities:

• Collaborate with internally 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
• Initiates and assesses 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.
• Performs review and approval of master and executed batch records to support drug substance (DS) drug product (DP) and finished goods (FG) disposition activities
• Maintains Quality Metrics to support process improvement activities
• Provides tactics to address compliance gaps or recommends 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

Knowledge and Skills:

• In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP Drug Product manufacturing
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality accuracy and timeliness objectives
• In-depth experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines; facilitates person in plant quality oversight of drug product manufacturing
• Strong experience in identifying assessing and mitigating potential risks utilizing quality risk management best practices
• 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 and advanced judgement and the analysis/synthesis of 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. QDocs Trackwise Veeva)

Education and Experience:

• Bachelors degree in a scientific or allied health field (or equivalent degree)
• Typically requires 8 years of experience or the equivalent combination of education and experience

$75-$80/hr

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 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