Quality Manager

Job Summary: Provides management of Compliance activities for the site following Innovation Labs policies, standards, procedures, and cGMPs.  This will include USA & Canadian regulatory compliance to the FDA and Health Canada regulations. The job includes organization and maintaining documentation. 

Key Responsibilities:

• Supervises and manages the activities of the Quality Compliance group. Assures job objectives are met on a timely basis.
• Leads team members in the deviation investigation process.
• Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Ensures control of systems, processes, and products through supporting review and approval of change notices and change control.
• Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed promptly.
• Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (ISO 22716, 21 CFR Parts 210 and 211).
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc.
• Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
• Collecting, collating and evaluating scientific data that has been researched by colleagues and providing strategic advice to senior management.
• Project managing teams of colleagues involved with the development of new processes and procedures.
• Reviewing company practices and providing advice on changes to systems.
• Provides administrative support by implementing systems, procedures, and policies; completing projects in support of compliance auditors.
• Complies with federal, state, and local legal requirements by studying existing and new legislation; enforcing adherence to requirements; advising management on needed actions.
• Collaborates with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.
• Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
• Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated and resolved.
• Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
• 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.
• Provides reports regularly, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts.
• Responsible for assisting with developing, reviewing, and executing validations to maintain Compliance with FDA and CGMP regulations.
• Performs additional assignments and responsibilities as determined by Vice President of Quality.

• 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.
• Bilingual in English & Spanish is preferred.

• Comprehensive Health Benefits package (Medical, Dental, Vision, Life, AD&D) 

• Competitive 401(k) match with immediate vesting 

• Paid time off (Vacation, Sick, Holiday, Summer Fridays)   
• Monthly birthday celebrations + other fun activities! 

• Daily subsidized meals 

iLABS (Innovation Labs) Inc. is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by federal, state or local laws. All employment is decided on the basis of qualifications, merit, and business need.