Sumitomo Pharma America, Inc. · 5 hours ago
Senior Director, Quality Assurance
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$212K/yr - $265K/yr
15+ years exp
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Responsibilities
Oversee the development and maintenance of a Quality Management System in full compliance with all regulatory requirements.
Ensure the development of QA systems are effective and in accordance with all government regulations and in compliance with GxPs.
Lead Management Reviews and routine Quality metrics reporting to monitor Quality System performance and identify areas for continuous improvement.
Manage the development and implementation of all necessary GxP related manuals, policies, processes/procedures and work instructions.
Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.
Provide oversight, as needed, on eQMS processes associated with deviations, investigations, CAPA, product complaints, risk management and change control as related to manufacturing and other GxP operations.
Ensure vendor oversight through audits, supplier qualification program and on-going performance management.
Ensure the organization remains in an Inspection Readiness state by managing an internal audit program for all GxP areas.
Manages Inspection Readiness activities and play a leadership role in partner audits and regulatory inspections.
Assist in the management of regulatory agency inspections.
Manage personnel in all accountable departments with a focus on retention, development and promoting a Quality culture.
Monitor industry trends and regulatory expectations to ensure evolution of the Quality Management System and compliance strategy.
Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.
Develop strategies and operational tactics for quality initiatives.
Other duties as needed.
Qualification
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Required
Bachelor’s degree or related science discipline required.
15+ years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a leadership role managing quality systems.
Experience in multiple disciplines within Quality (e.g. auditing, investigations, complaints, cGxP oversight, electronic systems management, PAI inspection readiness, commercialization and leadership).
Must have in-depth knowledge of FDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.
Significant work experience in a pharmaceutical, cGMP environment is required, strong working knowledge of FDA requirements and guidance documents.
Experience in evolving cGMP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
Demonstrated leadership successes in building and creating functions and infrastructure.
Experience with external CMO environments and as a part of a Quality team.
Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
Possess strong conflict management and negotiation skills.
Excellent verbal and written communication skills.
Self-motivated, able to work independently and be reliable and responsive.
Preferred
Advanced degree (MS, PhD, MBA) preferred.
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Unlimited paid time off
11 paid holidays
Additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in psychiatry and neurology, oncology, urology, women’s health, rare disease, and cell and gene therapies.
1,001-5,000 employees
H1B Sponsorship
Sumitomo Pharma America, Inc. 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
2023 (5)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase
