Vertex Pharmaceuticals
Senior Manager, GMP Operational Quality (Contract)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
General Summary:
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 and takes a role in the design and execution of new projects. The Sr. Quality Manager manages and develops personnel to support department and functional activities.
This is a 6 month contract.
Onsite at Leiden Center
Sun-Wed 7am-5:30pm
Key Duties and Responsibilities:
Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
Participate in cross-functional teams as an experienced Quality technical resource
Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex, as needed
Assist Change Control owners with ensuring compliance to change procedure requirements
Assess and approve change controls
Conduct quality investigations / deviations and review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for investigations resulting from deviations and OOS
Ensure appropriate CAPA actions are identified and addressed
Approve investigations / CAPAs
Identify, facilitate, and/or lead continuous improvement efforts
Maintain Quality Metrics to support process improvement activities
Provide tactics to address compliance gaps or determine enhancements to cross-functional quality systems
Conduct GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
Coordinate, facilitate and follow up on any QLT action items assigned
Identify and communicate risks and assist with risk mitigation plans as necessary
Support internal audit or external audit programs
Assist in preparation of audit responses
Manage audit CAPAs & metrics
Provide technical advice for partner and regulatory agency audits
Provide information to assist in budgeting and scheduling
Responsible for the following activities related to people management responsibilities
Talent Acquisition/ Recruiting/ Interviewing/ Selection/ Onboarding
Performance Management (goals, monitoring, reviews)
Monitoring / Supporting Employee Engagement and Retention
Succession Planning
Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs
Accountable to provide oversight of day to day operations
Assist with workforce planning/resource modeling and update through forecasting activities
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
In‑depth 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 mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
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 manage teams and develop personnel
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 judgment and the analysis/synthesis of a variety of information; able to work outside of precedent and take 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., QDocCS, Trackwise, 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
Pay Range $75‑$85/HR
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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 and takes a role in the design and execution of new projects. The Sr. Quality Manager manages and develops personnel to support department and functional activities.
This is a 6 month contract.
Onsite at Leiden Center
Sun-Wed 7am-5:30pm
Key Duties and Responsibilities:
Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
Participate in cross-functional teams as an experienced Quality technical resource
Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex, as needed
Assist Change Control owners with ensuring compliance to change procedure requirements
Assess and approve change controls
Conduct quality investigations / deviations and review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for investigations resulting from deviations and OOS
Ensure appropriate CAPA actions are identified and addressed
Approve investigations / CAPAs
Identify, facilitate, and/or lead continuous improvement efforts
Maintain Quality Metrics to support process improvement activities
Provide tactics to address compliance gaps or determine enhancements to cross-functional quality systems
Conduct GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
Coordinate, facilitate and follow up on any QLT action items assigned
Identify and communicate risks and assist with risk mitigation plans as necessary
Support internal audit or external audit programs
Assist in preparation of audit responses
Manage audit CAPAs & metrics
Provide technical advice for partner and regulatory agency audits
Provide information to assist in budgeting and scheduling
Responsible for the following activities related to people management responsibilities
Talent Acquisition/ Recruiting/ Interviewing/ Selection/ Onboarding
Performance Management (goals, monitoring, reviews)
Monitoring / Supporting Employee Engagement and Retention
Succession Planning
Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs
Accountable to provide oversight of day to day operations
Assist with workforce planning/resource modeling and update through forecasting activities
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
In‑depth 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 mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
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 manage teams and develop personnel
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 judgment and the analysis/synthesis of a variety of information; able to work outside of precedent and take 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., QDocCS, Trackwise, 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
Pay Range $75‑$85/HR
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