Quality System Manager

SUMMARY: Management oversight of Quality Systems and Compliance activities of the organization as per Innovation Labs policies, standards procedures, FDA regulations and guidelines. This will include USA & Canadian regulatory compliance to the FDA and Health Canada regulations. The job includes organization and maintaining of documentation.

DUTIES AND RESPONSIBILITIES:

1. Manages the activities of the Quality system and Compliance team while assuring that all job objectives are met on a timely basis.

2. Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site. Conduct all necessary training to self and others are necessary.

3. Writes and reviews Process Validation Protocols and final reports for equipment and OTC Products.

4. Collects and evaluates scientific data that has been researched by colleagues and providing strategic advice to senior management.

5. Reviews company practices and provides advice and drive changes to systems; SOP, Change Controls, CAPA, Validations, Metrology, Audits Investigations and CAPA etc.

6. Collaborates with other departments, identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.

7. Ensures control of systems, processes, and products through effective review and approval of change notices and/or change control.

8. Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed promptly.

9. Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (ISO 22716, 21 CFR Parts 210 and 211).

10. Provides Quality Management reports regularly, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts.

11. Responsible for assisting with developing, reviewing, and executing validations Protocols and reports to maintain Compliance with FDA and CGMP regulations

12. Performs additional assignments and responsibilities as determined by Vice President of Quality

QUALIFICATIONS:

· Must have a Bachelor's Degree in Chemistry, Biology, Environmental Sciences, or related field of study.

· Minimum 5 years related experience or equivalent.

· Must have GMP, Quality, and in-depth risk management knowledge.

· Must be able to interpret problems and effectively prepare surrounding communication

in a productive manner to management with clarity and accuracy.

· Must have strong authorship and be able to critically review investigations with Quality

risk management principles.

· Must be skilled in planning and organizing, conflict management, coaching others,

talent selection, developing others, decision making and building relationships.

· Manages positive relationships with external customers.