Senior Manager, GMP Operational Quality

Expert In Recruitment Solutions

🇺🇸 United States

On-site

Manager or above

9 months ago

CMOS
CAPA
GMP
Veeva

9 months ago

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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. 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 • 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 • Assists in preparation of audit responses • Manages audit CAPAs & metrics • Provides technical advice for partner and regulatory agency audits • Provides 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 • Assists with workforce planning/resource modeling and to 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 to 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 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., 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

Senior Manager, GMP Operational Quality · Expert In Recruitment Solutions

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