Sr Manager

What You'll 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 You'll 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*