Quality Regulatory Manager

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 the natural botanical ingredient industry, as they apply. This position reports to the COO.

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. 0ther duties as required.

III. Essential Skills and Experience:

Education or Equivalent: (Minimum required to perform job)

1. Minimum Bachelor of Science, MS preferred in fields such as, Chemistry, Pharmacy, Quality, Engineering or Biology with 5 years of experience in pharmaceutical operations

2. Minimum five years of experience at a Manager level or higher

3. Experience in the development of innovative and action-oriented quality programs are critical

4. Experience in international regulatory compliance is considered a plus

Knowledge/Skills Requirements:

1. Current knowledge and understanding of governing standards and regulations related to natural botanical ingredient extraction certifications.

2. Must have a demonstrated track record of talent management, building bench strength and setting clear objectives for performance and accountability.

3. Successful development and implementation of a quality strategy for a commercial manufacturing operations environment.

4. Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a manufacturing environment is preferred.

5. Comprehensive knowledge of certifications, regulatory organizations and requirements – FDA, OSHA, SEDEX, ISO9001, FSSC 22000 environmental groups, as well as international regulatory agencies and demonstrated experience facilitating inspections.

6. The position requires exemplary communication and organizational skills and the ability to work in a fast-paced cross-functional team environment to accomplish company and customer expectations.

7. Experience in supervising and mentoring junior staff

8. Detail-oriented with ability to accomplish objectives

9. Clear thinking/logical with strong personal organization skills

10. Able to work within a diverse, cross-functional team in a matrix organizational environment

11. Demonstrated competence in both written and verbal communication

12. Willing to travel (domestically and internationally)

13. Capacity to work within a fast-moving and demanding product development environment

14. Willingness and comfortable working in global environment being leader and Voice of Biovivo Science Quality Processes and Systems to the Leadership Team

15. Exhibit Self Governing and Autonomous judgement.

16. Steadfast and Self Assured to confront challenges and implement solutions.

17. Continuous Engagement and Collaboration to produce results and achieve goals

IV. Dimensions of Position:

Scope of Responsibility

Direct Reports: Up to 4 direct reports

V. Physical Requirements and Safety Considerations of the Position:

Physical Requirements:

Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Work Schedule:

Salaried

Essential Physical Job Tasks:

· Completion of administrative duties as indicated by position.

· Data entry and use of computer user interface tools including mouse, keyboard and any other applicable instruments.

o Setting up office, desk and workstation for minimal ergonomic risk factors as deemed necessary.

· Sustaining static postures

o Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position.

o Static stance/standing as required.

· Lifting and operating in an office environment

o File/Folder storage with non-repetitive light weightlifting, reaching and forward bending as necessary.

o Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.