SVP Quality Systems
Canton, Massachusetts
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: System One
Job ID: 383105
Date Posted: 11/05/2026
Shortcut: http://jobs.systemone.com/uF9o8G
Job Title: SVP Quality Systems
Location: Canton, Massachusetts
Type: Direct Hire
Work Model: Onsite
Salary: $350-$400k + 30% managerial bonus
Open to relocation
Responsibilities
- Partner with Operations, Manufacturing, Research & Development, Regulatory Affairs, Clinical, Medical Affairs, Supply Chain, Commercial, and other leaders to integrate quality into portfolio, capacity, supply, partnership, and operating decisions
- Lead risk-based qualification and performance oversight for critical suppliers, contract laboratories, contract manufacturers, tissue recovery and processing partners, distributors, and other service providers
- Build, develop, and retain a high-performing Quality organization with clear accountabilities, strong succession plans, and capabilities that scale with the business
- Lead the function’s budget, resource plan, performance objectives, and executive-level reporting on quality strategy, risk, inspection readiness, and remediation
- Own and continuously improve an integrated, risk-based QMS for company product and regulatory landscape
- Ensure disciplined execution across document control, training, deviations and nonconformances, investigations, CAPA, change control, validation, audits, supplier qualification, risk management, management review, data integrity, complaints, and recalls.
- Serve as the senior Quality representative with the FDA and other regulatory authorities, notified bodies, tissue-bank regulators and accreditors, customers, and business partners
- Lead inspection readiness, agency interactions, formal responses, commitments, and sustainable remediation
- Provide quality leadership from development through commercialization and lifecycle management, including design controls, technology transfer, validation, release, stability, post-market surveillance, complaints, field actions, and product changes
- Set and execute a clear, enterprise-wide quality vision aligned with company mission, growth priorities, product portfolio, development pipeline, and commitments to patients and healthcare providers
- Will shape quality strategy, strengthen our company-wide Quality Management System, and ensure that quality and compliance enable reliable supply, innovation, and sustainable growth
Requirements
- Education: BS degree in life sciences, engineering, pharmacy, or a related discipline; an advanced scientific, technical, or business degree is preferred
- Experience: Minimum of 15+ yrs. of progressive Quality exp. in regulated life sciences, including substantial leadership responsibility in commercial manufacturing
- Minimum of 7+ yrs. leading senior quality teams
- Exp. from the Biologics industry is preferred. Followed by Cell/Gene Therapy, human tissue products, combination products, or Med Device.
- Exp. from a mixture of small/startup to large size companies is a plus
- “MUST HAVES”: Expert exp./knowledge of working with the FDA and applicable FDA requirements and quality standards, including 21 CFR Parts 210, 211, 600, 820/QMSR, and 1271, as relevant; ISO 13485; and recognized tissue-banking standards
- BLA experience
- Proven exp. and accomplishments in engaging with FDA CBER for BLA submissions and post-approval Biologics compliance
- Exp. bringing a product to market (start to finish)
- Exp. “rebuilding”/transforming an entire quality dept. (knowing what needs to be done for a BLA vs. what could be done long term)
- Proven track record of developing relationships with other departments within a company to get the job done
- Exp. managing high level team members (i.e. Sr. Directors, Directors etc.)
- Proven track record of speaking with C Level executives and presenting in front of them and the Board of Directors
- Proven exp. overseeing an entire Quality Systems department
- Location: Westwood, MA area
- Start Date: ASAP!
System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#LI-
Ref: #558-Scientific
-
Equipment Supply Manager
Bellevue, WA
Job Title: Equipment Supply Manager Location: Bellevue, WA Type: Contract Compensation: $77.00 - $98.00 per hour Work Model: Open to: Remote, Hybrid, Onsite Responsibilities Act as the single point of accountability for development, delivery, start up ...
Date Posted: 10/26/2026 Recommended
-
QA Product Manager (Sterile Products)
Florham Park, New Jersey
Job Title: QA Product Manager (Sterile Products) Location: Florham Park, New Jersey Type: Direct Hire Compensation: Work Model: Hybrid – onsite and remote Responsibilities Lead and coordinate end-to-end technology transfer projects for drug substance a...
Date Posted: 10/08/2026 Recommended
-
Regulatory Affairs Labeling Operations Specialist
Plainsboro Township, New Jersey
Job Title: Labeling Specialist Location: Fully Remote - USA based Compensation: $100k-120k annually (commensurate with level of experience) Type: Long term project, annual salary plus 20 days PTO + 10 Holidays + 401k as well as the option to sign up fo...
Date Posted: 10/27/2026 Recommended
-
Manufacturing Associate III, Downstream Processing (3rd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate III, Downstream Processing (3rd shift) Location: Pennnington, New Jersey Type: Contract To Hire Work Model: Onsite- Monday-Friday 10pm-6am Pay Rate: $33-00-$37.50hr (Based on experience) plus $3 differential for 3rd s...
Date Posted: 10/30/2026 Recommended
-
Process Engineer MS&T
Princeton, NJ
Job Title: Process Engineer MS&T Location: Princeton, NJ Type: Contract To Hire Work Model: Onsite Hours: Mon-Fri; 8am-4:30pm Compensation: up to $60 per hour pending overall experience Responsibilities Functions as a technology and process subject mat...
Date Posted: 10/30/2026 Recommended
-
Senior Process Engineer
Tempe, Arizona
Job Title: Senior Process Engineer Location: Tempe, AZ Type: Contract Compensation: $56-$61.95hr Work Model: Hybrid Hours: Monday- Friday 8am to 5pm Overview We are seeking a Senior Process Engineer, to work on new product introduction process developm...
Date Posted: 11/05/2026 Recommended
-
Quality Assurance Engineer
Portage, Michigan
Job Title: Quality Assurance Engineer Location: Portage, MI Type: Contract Compensation: $47-$52/hr Work Model: Onsite Overview The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control and preventive a...
Date Posted: 10/26/2026 Recommended
-
Supply Planner
Vista, CA
Job Title: Supply Planner Location: Vista, CA Type: Contract Compensation: $35.00 - $48.00 Work Model: Onsite Hours: 40.0 Overview The Supply Planning Specialist will play a critical role in ensuring the availability of raw materials and finished goods...
Date Posted: 09/21/2026 Recommended
-
Histotechnician
Ridgefield, Connecticut
Job Title: Histotechnician Location: Ridgefield, CT Type: Contract Work Model: Onsite Hours: 40 hours Overview The Histotechnician / Spatial Biology Specialist will support the Discovery Research team in Ridgefield, CT, helping expand spatial biology c...
Date Posted: 11/05/2026 Recommended
-
Document Control Analyst
Bellevue, WA
Job Title: Document Control Analyst Location: Remote Type: Long term Contract Compensation: $32.00 - $46.00 per hour Responsibilities Administer and maintain Electronic Document Management System (EDMS), ensuring compliance with document lifecycle requ...
Date Posted: 10/26/2026 Recommended
-
Engineering Project Manager
Mahwah, NJ
Job Title: Engineering Project Manager Location: Mahwah, NJ Type: Contract Compensation: $62 - 67.47/hr Work Model: Hybrid- onsite and remote (4 days onsite) Overview The Project Manager will spend a significant portion of their time coordinating with ...
Date Posted: 09/30/2026 Recommended
-
Compliance & Regulatory Specialist Consumer Products
Ontario, CA
Job Title: Compliance & Regulatory Specialist, Consumer Packaged Goods Location: Ontario, CA Type: Direct Hire Compensation: $70,000 Work Model: Onsite Hours: 40.0 Responsibilities Ensure compliance with FDA regulations, GMP requirements, labeling stan...
Date Posted: 11/05/2026 Recommended
-
Avionics Supply Chain Program Manager
El Segundo, CA
Job Title: Avionics Supply Chain Program Manager Preferred Location: Greater LA candidates strongly preferred Type: Contract Pay range: $74 to $92 per hour Travel expected up to 30% of the time Responsibilities Team up with Integrated Product Team lead...
Date Posted: 09/22/2026 Recommended
-
IT Program Manager - Data Systems
Lake Mary, FL
Job Title: IT Program Manager - Data Systems Location: Lake Mary, FL Type: Direct Hire Work Model: Onsite Hours: 40.0 Overview System One is looking for a full-time Program Manager located in Lake Mary, FL. The Program Manager, Remote Services is respo...
Date Posted: 10/07/2026 Recommended
-
Avionics Supply Chain Program Manager
Kent, WA
Job Title: Avionics Supply Chain Program Manager Preferred Location: Seattle-area candidates strongly preferred Type: Contract Pay range: $89 to $110 per hour Responsibilities Team up with Integrated Product Team leadership to capture product concepts,...
Date Posted: 09/22/2026 Recommended
-
Regulatory Science Senior Specialist
Mahwah, NJ
Job Title: Regulatory Science Senior Specialist Location: Mahwah, NJ Compensation: $48/hr Hours: 8:00am to 5:00pm Type: Contract Overview The role will provide primary technical support for a product transfer project involving orthopedic medical device...
Date Posted: 10/30/2026 Recommended
-
Manufacturing Technician - Albumin Bulk
Los Angeles, California
Job Title: Plasma Classification Associate Inspector Location: Los Angeles, CA Type: Contract Compensation: $22/hr + 10% shift differential Work Model: Onsite Hours: 10pm to 6 am Overview The manufacturing technician is an integral part of the overall ...
Date Posted: 10/22/2026 Recommended
-
Senior Hardware Engineer
Pittsburgh,, PA
Job Title: Senior Hardware Engineer Location: Pittsburgh, PA Type: Contract Contractor Work Model: Hybrid System One is looking for an enthusiastic self-motivated Senior Hardware Engineer who thrives in a fast-paced environment. The successful candidat...
Date Posted: 10/13/2026 Recommended
-
Scientist I
Ridgefield, Connecticut
Job Title: Scientist I Location: Ridgefield, Connecticut Type: Contract Compensation: $33.25/hr Work Model: Onsite Hours: 40.0 Responsibilities: Duties include performing experimental work in the Spatial Biology Lab including sectioning of FFPE tissue ...
Date Posted: 10/28/2026 Recommended
-
Principal Investigator (MD/DO)
Indianapolis, Indiana
Job Title: Principal Investigator Location: Indianapolis, IN Type: Full-time Work Model: Onsite Overview If you're an Internal Medicine/Specialist Physician looking for a way to stay engaged in medicine, contribute to the advancement of new therapies, ...
Date Posted: 10/15/2026 Recommended
-
Principal Investigator (MD/DO)
Pittsburgh, Pennsylvania
Job Title: Principal Investigator (MD/DO) Location: Pittsburgh, PA Type: Full-time Overview We're seeking an experienced Principal Investigator (MD or DO) to support the growth and development of a new clinical research site. If you have prior experien...
Date Posted: 10/15/2026 Recommended
-
Packaging Engineer
Stamford, CT
Job Title: Packaging Engineer Location: Stamford, CT Work Model: Hybrid (Up to 2 days per week remote) Hours: M-F 8am-5pm Compensation: $75.00/hr Type: 2-year contract, Potential for extension or conversion to permanent Responsibilities Develops and de...
Date Posted: 10/02/2026 Recommended
-
Purification & Analytics Scientist
Boston, Massachusetts
Job Title: Purification & Analytics Scientist Location: Boston, MA Type: Contract to Hire Compensation: $84.13 Work Model: Onsite Hours: Standard business hours Security Clearance: Not specified Overview: Join a growing U.S. biotechnology organization ...
Date Posted: 10/12/2026 Recommended
-
Product Field Action Coordinator
Redmond, Washington
Job Title: Product Field Action Coordinator Location: Redmond, WA Type: Contract Compensation: $24/hr Work Model: Hybrid Hours: M-W onsite; Th-Fr remote. 8-5 Overview Responsible for coordinating Product Field Action Executions according to defined str...
Date Posted: 10/14/2026 Recommended
-
Electrical Engineer
Weston, FL
Job Title: Electrical Engineer Location: Weston, FL Type: Contract Compensation: $72 - $77.41 Work Model: Onsite Hours: 40.0 Responsibilities Lead the electrical design and development of a major robotic subsystem. Translate product and system needs in...
Date Posted: 09/18/2026 Recommended
-
Electrical Engineer
Weston, FL
Job Title: Electrical Engineer Location: Weston, FL Type: Contract Compensation: $76-$81.61/hr Work Model: Onsite Hours: 40 Responsibilities Lead the electrical design and development of a major robotic subsystem. Translate product and system needs int...
Date Posted: 09/18/2026 Recommended
-
Principal Design Engineer (Mechanical / Mechatronic)
Boston, Massachusetts
Job Title: Principal Design Engineer (Mechanical / Mechatronic) Location: Boston, MA Type: Contract to Hire Compensation: $73.08 an hour Work Model: Onsite – onsite Hours: Standard business hours Security Clearance: Not specified Overview: Join a growi...
Date Posted: 10/22/2026 Recommended
-
Document Control Specialist I
Round Lake, Illinois
Job Title: Document Control Specialist I Location: Round Lake, Illinois Type: 2 month Contract Work Model: Onsite Hours: 1st Shift - 8AM to 5PM - Wednesday to Sunday Hourly Rate: $21.25 Overview Global Healthcare company looking to hire a Document Cont...
Date Posted: 10/23/2026 Recommended
-
Marine Structural Engineer
Houston, Texas
System One is currently seeking an experienced Marine Structural Engineer to be based in Houston, TX as part of our dynamic and growing global Ports & Terminals (P&T) team, and to immediately support several major ongoing engagements with both public a...
Date Posted: 10/01/2026 Recommended
-
Warehouse Operator
Branchburg, New Jersey
Job Title: Warehouse Operator Location: Branchburg, NJ Type: Contract to Hire Compensation: $21.00 - $25.00/hr. (based on experience) Work Model: Onsite Hours: 7 a.m. - 3 p.m. Must be able to work overtime and Saturdays when needed Position Overview We...
Date Posted: 11/05/2026 Recommended
⚠️ Protecting Job Seekers from Identity Scams
At System One, your privacy and security are important to us. As job-related scams continue to target job seekers, we want to help you recognize and avoid common recruitment fraud. Identity theft scams often involve individuals, also known as "scammers," posing as recruiters or employers to obtain sensitive personal information, such as Social Security numbers, bank account details, or copies of driver’s licenses, with the goal of stealing identities, accessing financial accounts, or creating fraudulent accounts in a victim’s name.