Sr Manager, Quality Operations
Sr Manager, Quality Operations
Posted on :
12-06-2025
Employer Active
1 Vacancy
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Job Description
At Fullscript were not just changing healthcarewere making it whole.
We help 100000 healthcare practitioners support 10 million patients with a platform that delivers evidence-based health solutions diagnostic support and practitioner toolsall in one place.
Healthcare today is disconnected. Were fixing that. Fullscript makes it easier for practitioners to treat the whole person not just symptoms so patients get the support they needwhen they need it.
Were building a better wayone where healthcare is connected complete and built for impact.
About The Role:
The Sr. Manager Quality Operations leads Quality Operations across all distribution centers to ensure compliance with internal procedures and regulatory standards enforced by the FDA Health Canada and other relevant government agencies.
This role is responsible for leading quality assurance and operational initiatives across multiple business units to identify and drive quality improvement and regulatory compliance. This critical role provides guidance and support to ensure the highest level of product quality and customer satisfaction.
This is a hybrid role that requires mandatory in-person attendance during the initial onboarding period as well as travel throughout the year. If youre passionate about ensuring top notch quality and enhancing how we operate - this is the role for you.
What Youll Do:
- Oversee and manage daily warehouse quality activities and a team of Quality Operations Team
- Manage the sanitation hygiene housekeeping and pest control programs at all distribution centers to ensure cGMP and regulatory requirements are met including maintenance of SOPs and completion of records.
- Manage critical temperature controls at all Fullscript warehouse locations and the suitability and effectiveness of the monitoring equipment and systems.
- Ensure that product receiving returns and disposition processes are suitably documented and in compliance with quality requirements and specifications.
- Lead and oversee quality process implementation and compliance across warehouse functions including good documentation practices and audit readiness.
- Manage and administer the internal audit program across all warehouse locations
- Ensuring effective audit scheduling and practices
- Completing timely internal audits across all warehouse locations
- Establish and maintain the upkeep of internal audit protocols and that internal auditors are suitably qualified / trained. Drive the completion of training requirements specifically with regards to cGMP training and quality operations processes.
- Provide training and mentorship to staff to ensure a deep understanding of regulatory and quality expectations.
- Serves as a primary quality operations representative during external audits / regulatory inspections ensuring all compliance and quality requirements are met and responsible for follow-up actions as needed.
- Supervises mentors and guides the Quality Operations team providing leadership and support to promote a proactive and effective quality management approach.
- Support overall document control effectiveness and ensure good document control practices are observed throughout all distribution centers.
- Participate in the CAPA program by ensuring timely and effective CAPA investigations root cause analysis action plans and the completion of actions.
- Monitor and provide metrics for the reporting of quality operations and distribution center quality performance.
- Facilitate an effective training program ensuring that quality operations and distribution center personnel complete required cGMP and SOP training requirements.
- Ensure operational quality compliance with all applicable regulatory requirements and quality standards.
- Participate as a key team member in external audits (FDA NSF State Customer)
- Other duties as assigned
What You Bring To The Table:
- Bachelors or equivalent degree in Life Sciences Food Pharma Chemistry or related field experience.
- 5 years Quality Manager experience within a regulated industry. Preferably in the food & dietary supplement industry. (Drug / medical device experience may be considered).
- Travel required 20%-40% depending on business needs.
- Third-party Quality Auditing experience e.g. FDA UL USP NSF etc.
- PCQI certification.
- Working knowledge of Foods and Dietary Supplements cGMP regulations including crisis management and food defense.
- Meticulous attention to detail superior organizational capabilities and a keen investigative approach are crucial.
- Experience growing and mentoring team members
- Proactive self-starter with the ability to concentrate and drive tasks to completion autonomously.
- Exceptional verbal and written communication skills are required for effective dissemination of information and collaboration with colleagues across all organizational levels as well as potential interactions with regulatory agencies
- Proficiency in Google Suites and/or Microsoft Office applications
- Working knowledge of eQMS WMS and ERP systems is preferred.
Why Youll Love Fullscript:
- Competitive Total Rewards offerings
- 401(k) savings plan & matching (within US)
- Customizable Health Benefits
- Flexible Paid Time Off program
- Discounts on Fullscript catalog of products for self family & friends
- Training allowance and company-wide learning initiatives
- Work Wherever You Work Well*
Why Fullscript
Great work happens when people are supported challenged and inspired. Here youll be part of a team that:
Values innovationwe push boundaries and always look for better ways.
Supports growththrough learning mentorship and meaningful work.
Cares about balancewith flexible work options and time off when you need it.
Apply nowlets build the future of healthcare together.
Fullscript is an equal-opportunity employer committed to creating an inclusive workplace. Accommodations are available upon requestemail for support.
Before joining the team all candidates who receive and accept an offer will complete a background check.
IN THE NEWS: Fullscript acquires Rupa Health
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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