Katalyst CRO ยท 20 hours ago
Sr.GMP Operational Quality
Boston, MA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is seeking a Sr. Quality Manager who will serve as an advanced technical resource in quality assurance and compliance. This role involves managing and developing personnel while coordinating activities on multiple complex projects to ensure compliance and resolve quality issues.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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)
Qualification
Required
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 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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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