Manage a diverse group of employees to ensure overall goals and objectives are met for the Quality Department. Involves scheduling work priorities and time-line, allocating resources (delegation) and development of personnel. As a Manager, is accountable for the results of themselves, their team and establishing a positive working environment.
2. Manage and operate Site Quality systems; receipt, testing, and all required quality control and quality assurance activities. Manages site quality systems and processes to assure all department actions and activities comply with relevant regulatory requirements, with the authority to shut down any operation if questions arise regarding compliance or other issues as needed.
3. Monitors the site’s results to quality and compliance goals; develops improvement plans as needed. Stays current with compliance regulations and recommends changes as appropriate as they impact the plant.
4. Prepare and review department budgets and leads cost and efficiency improvement efforts with the Quality Function as well as across the site in general.
5. Insure compliance with GMP , DEA , and FDA regulations.
6. Contribute to and maintain an active Safety/Quality program.
7. Lead, coach, and train employees toward team concept. Train employees on proper testing/laboratory procedures, methods and techniques as well as GMP requirements. Utilizes performance management tools routinely to build/maintain a strong, effective team.
8. Direct and facilitate investigations and resolution of process deviations, abnormal results, customer complaints and inquiries.
9. Anticipate and identify customer needs. Seek ways to continually improve customer satisfaction.
10. Insure tests are performed accurately and in a timely manner in order to meet production schedule and release dates to service customer.
Department Specific Functions:
1. Supports Pharma Quality Policy, regulatory strategies and audit process.
2. Manage the department by recommending personnel, equipment, facility, budgeting, and training and development needs for the department.
3. Other duties as assigned with or without accommodation.
Education Required / Preferred:
1.Bachelor of Science Deegree in Chemistry / Biology, Engineering, or related field. 2.Master of Science Degree preferred. Experience:
1.A minimum of 8 years leadership experience in the pharmaceutical industry or a laboratory environment. 2.Familiar with cGMP regulations and good laboratory procedures. 3.Laboratory experience in a manufacturing environment would be preferred.Preferred Skills / Qualifications:
1.Thorough understanding of chemistry and testing procedures; analytical and problem solving skills; supervisory skills and experience.2.Strong communication skills (speaking and listening); knowledge of GMP regulations; technical writing; conflict resolution skills; computer literate; team building skills; a desire to develop others through coaching and facilitation. 3.Must have knowledge and understanding of applicable global regulations, GMP and compendial requirement.Skills / Competencies:
1.Must be able to demonstrate the following: Professional knowledge in job related techniques, willingness to adapt to change, show initiative and take risk, values diversity, communicate effectively (written and oral), plan and organize, teamwork, influence others, continuous improvement, fiscal responsibility, delegate, negotiate, and develop subordinates. 2.Also, must have the ability to drive cost reduction while continuously improving performance, as well as the ability to lead employees in making changes.Other Skills:
1.Skilled in the use of statistical techniques as applied to vendor, process and product quality control. 2.Requires understanding of marketing, accounting, financial and business management principles.
- The Quality Director will perform the above-mentioned duties at the Hobart, NY Site.* The work will be done mostly in the office or laboratory environment.* Position may require travel to other Sites or other companies.
The Alexandria Group - 21 months ago
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