Director of Quality (Pharmaceutical Manufacturing)

GENERAL SUMMARY: Responsible for the organizational elements of First Priority’s Quality Control, Quality Assurance and R&D. This responsibility includes, but is not limited to, the effective planning and organization of personnel and workflow utilization in order to implement the timely submission, approval, validation, testing and release of products and processes in accordance with applicable internal quality system policies, procedures, and external regulations and standards that govern the products manufactured, labeled, tested, stored, promoted and/or distributed by or for First Priority Inc.

PRIMARY RESPONSIBILITIES: Promoting quality achievement and performance improvement throughout the organization. Leads all regulatory inspections and responsible for all regulatory responses review and final review of all regulatory filings prior to submission. Setting QA compliance objectives and ensuring that targets are achieved. Assessing the product specifications of the company and its suppliers, and comparing with customer requirements. Working with purchasing staff to establish quality requirements from external suppliers. Ensuring compliance with national and international standards and legislation. Establishing standards and clearly defined quality methods for staff and all employees to apply. Defining quality procedures in conjunction with operating staff. Setting up and maintaining controls and documentation procedures. Identifying relevant quality-related training needs and delivering training. Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary. Supervising managerial staff ensuring that objectives are established and accomplished. Writing technical and management systems reports. Ability to use change intervention tools and techniques to gain acceptance of a quality culture. Liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications. Participate in special projects when the business need arises.

QUALIFICATIONS: Education and/or Experience: B.S. degree in Biology or Chemistry or related sciences Minimum of 10 years of pharmaceutical experience Must have FDA regulatory knowledge and experience. Minimum of 5 years’ experience leading a Quality function. Knowledge and/or experience in product formulation of liquids, ointments, powders and tablets and injectables. Knowledge of cGMPKnowledge of Regulatory Affairs required Compliance and Validation experience preferred Strong communications skills, ability to problem solve and use of critical thinking. Good level of computer literacy Change agent with the ability to influence all levels in the organizationTRAINING: On the job training: SDS/Hazardous Awareness Good Manufacturing Practices (GMP) Laboratory Procedures Product knowledge Reasoning Ability: Teamwork/collaborative style of management Good business acumen, judgment and maturity with the ability to differentiate strategic vs. non-strategic opportunities Excellent organizational skillsWORK ENVIRONMENT:Lab environment involving chemicals, solvents, gasses, and glassware Laboratory bench work and documentation Low to medium noise level Temperature controlled environmentTOOLS AND EQUIPMENT:Computer and printer PhoneCopy machine Appropriate personnel protective equipment (when necessary) Lab equipment Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

FLSA: Exempt

Benefits: 401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Tuition reimbursement Vision insurance