What are the responsibilities and job description for the Quality, Regulatory and Compliance Manager position at BioVivo Science?
Company Description
Biovivo Science's mission is to harness the power of nature to innovate and create premium, science-driven, and future-ready botanical solutions that nourish health, vitality, and global sustainability. We do this through leading the future of natural health innovation by uniting the power of plants, science, and unmatched capabilities to nourish life across the globe.
Role Description
I. Position Overview:
The Quality, Regulatory, and Compliance Manager is responsible for management of all Quality compliance systems and provide leadership in the compliance efforts for the manufacturing production processes. The Quality, Regulatory and Compliance Manager must demonstrate deep and broad knowledge of the quality functions in Food Safety.
II. Specific Tasks, Duties and Responsibilities:
1. Develop, implement, and communicate a clear strategic vision for quality
2. Must maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate, and prevent quality and/or regulatory problems.
3. Drives the implementation of the QMS system, put in place the processes and procedures, and creates the organization needed to meet and exceed corporate priorities.
4. Leads the quality function to assure operational excellence in and compliance to standards, quality policies and processes
5. Ensures Quality & Compliance management teams establish and operate inspection-ready, compliant facilities management operations
6. Maintain strong relationships with customers, regulatory organizations, quality trade associations and other industry contacts.
7. Plan, prepare, coordinate, and implement 3rd party auditing recommendations across the Quality Management Systems and ensure accuracy of testing results.
8. Lead the compliance efforts for production process
9. Author and negotiate terms of Quality Agreements with clients and vendors.
10. Provide quality guidance and direction to all operational department heads.
11. Assure adequate Quality review and approval of manufacturing documentation, deviations, CAPAs, SOPs, change controls, training documentation, protocols/reports. Ensure completeness, accuracy and compliance of all documentation.
12. Will coordinate and oversee regular, internal audits for quality, regulatory and safety.
13. Prepare trend reports related to Quality performance of the operation (such as, but not limited to, Deviation, Change Controls and CAPAs.)
14. Ensure Quality Systems are compliant with corporate and site procedures as well as industry standards such as, but not limited to, Annual Product reviews, Complaints, Investigations, Root Cause Analysis, Corrective and Preventative Actions, Batch Disposition, and Training
15. Work with operations team to develop quality control systems for product lines.
16. Lead in Regulatory Inspections and customer audits including interface for all FDA, state and third-party audits.
17. Work with supply chain to ensure the quality of feedstock and ingredients
18. Develops, Manages and Conducts all employee trainings related to quality and operations.
19.Manages all Quality and Food Safety Programs.
Qualifications
- Quality Assurance and Quality Control expertise, including knowledge of relevant standards and regulations
- Experience in process improvement, risk management, and compliance evaluation
- Strong analytical, problem-solving, and decision-making skills
- Excellent communication and leadership abilities to direct and support teams
- Bachelor’s degree in Quality Management, Life Sciences, Engineering, or a related field
- Extensive knowledge in Quality Management Systems
- Certification PCQI and SQF
- Extensive Knowledge of Kosher, Halal, and Organic Certifications
- Experience with ISO 9001, HACCP and FSSC 22,000 certification a must.