Vice President, Quality & Compliance
Bio-Concept Laboratories, Inc. is a pharmaceutical and ophthalmic product development company with operations in Salem, NH. We currently have an opening for a Vice President – Quality and Compliance.
The VP of Quality and Compliance will be responsible for the strategic leadership and successful implementation, execution and maintenance of Quality Systems, Assurance, Control and Compliance for developing products for IND and NDA submissions. This person will ensure all FDA regulations for pharmaceutical manufacturing are met at this company.
This individual will be responsible for the direction of Quality Assurance, Quality Control, and Regulatory Compliance for the sterile manufacture of ophthalmic, parenteral and other drug products.
The VP of Quality and Compliance will report directly to the CEO and working with the CEO will develop and implement a set of quality and regulatory compliance strategies for sterile liquids manufacturing, formulation, testing and release for both clinical and low volume commercial manufacturing contracts.
This individual will provide technical and quality guidance to the company’s other functional areas by working closely with the VP of Business Management and the VP of Product Technology
The VP of Quality and Compliance will directly oversee and be responsible for all quality, testing and regulatory functions including Quality Assurance, Chemistry Quality Control, Microbiology, Stability and other Testing, and Regulatory Affairs, as well as, all chemistry and testing laboratories.
This position is responsible for the management and coordination of activities required to meet quality and compliance standards. It acts to liaise with other senior staff throughout the organization to ensure that that quality is functioning properly and integrated throughout the operation. Where appropriate this person will advise on changes and their implementation and provide SOP’s, training, tools and techniques to enable other departments to achieve the company quality and compliance goals.
The VP of Quality and Compliance will develop, implement and maintain quality systems aimed at ensuring the compliance to CGMP and ISO. This individual will be responsible for; the implementation of all regulations for GMP manufacturing; build sustainable improvements in the organizational quality and testing plans; implement, and direct overall work flow; personnel assignments; management of quality and regulatory programs; compliance expenses, budget, and communications.
This person must drive process improvement activities to ensure adherence to CGMP requirements: the VP of Quality and Compliance will be responsible for successful execution of FDA and client audits.
The VP of Quality and Compliance must demonstrate strong leadership skills to inspire team confidence and respect while motivating team members in a creative and effective manner.
Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
Requirements include a Bachelor's degree in Chemistry/Biology or related field, 15+ years of Quality operations experience, especially quality improvement experience and 10 years of management or supervisory experience; experience with project management and/or quality improvement. Also required is 8 years at a senior management position working in a CGMP regulated sterile fill-finish pharmaceutical manufacturing environment. Knowledge of quality improvement concepts and methods.
The company offers a competitive salary and excellent benefits including medical, dental, short-term disability, 401(K), 125 Cafeteria Plan, and tuition reimbursement. Interested applicants should forward their resume to email@example.com