Sr.GMP Operational Quality

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.

• 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
• 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)

• 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