Assistant Director of Quality
pay ~ up to 135k
The Assistant Director, Quality is responsible for the quality assurance and quality control of raw materials, packaging, work-in-process, and finished goods to ensure the safety, efficacy, consumer/trade acceptability, and regulatory compliance of the Company's products. In addition, the Assistant Director, Quality has the responsibility to assist the Director, Quality in guiding the Company's activities so that they comply with all relevant regulatory requirements and Company policies/procedures.
ESSENTIAL JOB FUNCTIONS
- Directs and leads Company Quality activities, specifically those in the Quality Assurance (inspection), Quality Control (analytical laboratories), and Validation Departments.
- Oversees Company quality system including third-party service providers' compliance with Health Canada regulations.
- Leads, mentors, and applies contemporary knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation, and understanding of test results, for both qualitative and quantitative analyses.
- Directs and leads the training program for all Quality personnel while evaluating subordinates through reviews and periodic discussions and fosters teamwork, customer service, and cross-functional relationships.
- Ensures that Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Documentation Practices (GDPs) are trained on and adhered to across Operations.
- Coordinates the Corrective Action Preventive Action (CAPA) process through the assignment and completion of comprehensive Investigation Reports.
- Monitors all GMP/GDP-related activities of the Company to ensure compliance.
- Supports policies, programs, and initiatives identified by the Director, Quality to ensure that current and emerging regulatory and Company requirements are met.
- Coordinates and supports internal audits conducted by the Manager, Compliance and implements all required corrective and preventive actions.
- Supports Director, Quality in overseeing and directing the coordination with Research & Development and/or Manufacturing on matters concerning process development, process engineering, and validation.
- Identifies the need for and implements the use of outside testing facilities on matters pertaining to quality control or quality assurance when existing Company resources do not suffice.
- Communicates with chemical suppliers, packaging suppliers, and contract manufacturers to ensure compliance with regulations and the Company's specifications/expectations.
- Monitors the creation and maintenance of written specifications for all raw materials, packaging, and finished goods to ensure quality, identity, potency, uniformity, purity, and any other relevant factors pertaining to an item's suitability for use.
- Partners with other disciplines to qualify new chemical suppliers, packaging suppliers, and contract manufacturers, in conjunction with Purchasing, Manufacturing, Marketing, and Technology.
- Supports the development and execution of appropriate audits of strategic suppliers of raw materials, packaging, and contract manufacturing.
- Keeps abreast of current scientific and/or compliance trends, practices, and developments which would impact the Company, and advocates changes as appropriate.
- Supports the coordination with Analytical Development on the development of methods and procedures relative to bringing products to and through the manufacturing process. Provides input into formulation as necessary.
- Ensures optimum performance of the Quality Control, Quality Assurance, and Validation Departments. Recommends, develops, and implements techniques to improve productivity, increase efficiency, minimize cost, and maintain state-of-the-art practices.
- Provides the direction and oversight necessary to ensure the completeness, timeliness, consistency, accuracy, and security (including storage) of Quality data including entries, calculations, reports, and any other type of data used as pertinent to the operation of the Company.
- Ensures the timely and meticulous administration of a sustained and compliant stability test program for new products and existing products.
- Exercises administrative control over the personnel assigned to Quality (e.g., interviewing, training, orientation, salary reviews, performance appraisals, etc.), in conjunction with the Director, Quality and Director, Human Resources & Organizational Development.
- Complies with the Affirmative Action Plan in all conditions of employment to ensure that equal opportunity efforts and results are consistent with Company policies and practices.
- Strengthens the Quality Department by contributing innovative ideas, expertise, knowledge, high professional standards, team spirit, and pride in the Company.
- Through individual guidance, mentors and coaches Quality Control, Quality Assurance, and Validation personnel to grow in their positions, develop their skills and future potential, and maintain a high level of knowledge in the Quality profession. Trains each staff member thoroughly in established regulations, Company policies and SOPs, and the Company's philosophy and business practices.
- Develops and administers training classes for Operations employees in GMPs, GDPs, GLPs, and SOPs.
- Provides, in conjunction with the Director, Quality, primary input in the formulation of long and short-term operating budgets and other objectives of the Quality Department; and ensures adherence.
- When requested by the Director, Quality, participates in FDA inspections.
- Provides reports on a regular basis and as needed or requested to keep Director, Quality informed about activities and progress on projects.
EDUCATION AND EXPERIENCE
- Bachelor's degree required. Master's degree desired. Background in relevant sciences preferred.
- Minimum of 10 years of management experience with 7 years in an OTC manufacturing environment with a proven track record in analytical and/or microbiological pharmaceutical laboratories along with Quality management, and analytical pharmaceutical laboratory problem solving.
- Experience in developing and implementing GMP training programs.
SKILLS AND ABILITIES
- Familiar with risk and science-based approaches for all aspects of Quality management.
- Able to independently identify and resolve complex problems by utilizing both functional and scientific technical skills.
- Ability to persuade internal and external customers to take appropriate action.
- Considerable management and organizational skills are required to successfully perform the planning, directing, reporting, and administrative responsibilities of this position.
- Knowledge of general business practices and financial decision making.
- Strong leadership skills with the ability and inclination to motivate and direct internal resources toward high quality and timely execution.
- A comprehensive knowledge of all aspects of quality control and quality assurance, with a broad understanding of GMP, GDP, and GLP regulations as well as knowledge of other federal and state regulations.
- Good judgment and problem solving skills.
- Comprehensive knowledge of contemporary principles and practices in an OTC manufacturing environment.
- Ability to coordinate work with other departments toward common goals.
- Understanding of manufacturing information systems and database structure.
- Ability and inclination to handle confidential information with extreme discretion.
- Computer literate in Windows environment (including Word, Excel, and PowerPoint) at intermediate skill level.
- Familiarity with the usage of Quality Systems Software (MasterControl).
- Excellent oral and written communication skills.
- Strong analytical thinking with the ability to develop and communicate sound, insightful, and useful conclusions from data.
- Ability to effectively handle multiple concurrent responsibilities while maintaining close attention to details.
- Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from Management and comply with Company policies.
The following positions report directly to the Assistant Director, Quality:
o Manager, Quality Assurance
o Manager, Quality Control
o Engineer, Quality