Senior Manager, QA Operations
Building on Sumitomo Pharmas 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.
SMPA is a Sumitomo Pharma company. [For more information, visit (link removed)]
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, QA Operations based at our Cell Processing Center in Morrisville, NC. The successful candidate will be an integral member of a growing Quality team and work cross-functionally with key stakeholders.Critical roles include ensuring compliance with regulatory requirements and company procedures, supporting the build-out of our regenerative medicine manufacturing facility, supporting Inspection Readiness, and providing quality oversight for our new facility.
This critical role will report the Associate Director of Quality Operations and will be instrumental to the growth and success of our department and company. We seek an individual that can complement and expand the strengths of our team. The successful candidate must be agile and have strong interpersonal skills, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.
Job Duties and Responsibilities
Lead a team of QA Specialists to ensure robust QA oversight of all aspects of the CPC facility to ensure compliance with current regulations and successful facility start up.Have a prominent role in Inspection Readiness activities for new suites and products to ensure successful audits (internal & external).
Support the Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.
Mentor the team to increase capabilities in the Quality Management System through one-on-one training on deviations, Change Controls and CAPAs.
Prepare and present quality related updates, metrics, and trends at internal meetings, quality management review, and partner meetings.
Determine and ensure proper qualification, quality oversight and management of tissue source centers, treatment centers, cell, and medical device CDMOs.
Manage Change Notifications obtained from Suppliers and ensure compliant follow-up to ensure changes are assessed in the QMS.
Work with global colleagues to ensure successful Tech Transfer of clinical stage products into the CPC facility.
Establish the Material Review Board to ensure effective management of materials in compliance with global procedures.
Key Core Competencies
Excellent written and oral communication skills.Effective at training and developing quality staff for future staff and company growth ensuring staff retention and good morale Excellent collaboration, negotiation, mentoring and team leadership skills.
Team goal setting and planning to achieve results.
Effective application of analytical and investigational techniques to identify root cause and problem solving.
Advanced knowledge of aseptic cell processing, testing, and release requirements.
Support company growth through effective staff development.
Inspection Readiness and/or auditing experience strongly preferred.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
Education and Experience
Minimum 8 12 (w/o Masters) or 6 8 years (with Masters) years of relevant experience in biotech or pharmaceutical industryAdvanced knowledge and experience in aseptic cell processing quality best practices and regulatory requirements, including 21 CFR 210/211, 600s, and 1271.
Expert level knowledge of GMP regulations and FDA CBER requirements, Guidance documents, and industry best practices.
Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA CBER/EMA, and ICH.
The base salary range for this role is $142,000 to $186,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data- All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
- Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
- Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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