Sr.GMP Operational Quality
Katalyst Healthcares and Life Sciences
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 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
Vacancy posted 15 hours ago
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