Deputy Director, Manufacturing Staff

Direct Staffing Inc; Swiftwater (Monroe County); On-site; USD 100,000 - 160,000; Full time

Job summary

Une entreprise leader dans la fabrication pharmaceutique recherche un Deputy Director, Manufacturing. Ce poste exige des compétences en leadership, une connaissance approfondie des CGMP et une expérience significative dans un environnement de qualité régulé. Vous serez responsable de la direction de l'équipe, de l'assurance qualité et de l'atteinte des objectifs de production.

Qualifications

• Minimum 10-15 ans d'expérience dans l'industrie pharmaceutique.
• Expérience en gestion dans un environnement de qualité réglementée.
• Connaissance approfondie des CGMP et exigences réglementaires.

Responsibilities

• Fournir direction et leadership dans la fabrication.
• Assurer le respect des normes de qualité et de sécurité.
• Gérer l'équipe et évaluer les performances des rapports directs.

Skills

Leadership

Quality Management

CGMP Knowledge

Communication

Problem Solving

Education

Bachelor’s Degree in Life Sciences, Engineering or Management

Job description

The Deputy Director, Manufacturing will be responsible for but not limited to the following:

• Provide leadership and direction to the Meninge Conjugate and Diphtheria Toxoid Manufacturing to meet the established strategic vision of the areas of B46 and B56. This Deputy Director is responsible to ensure the manufacturing facilities and equipment within his/her control is properly maintained. In addition, this position will verify the continued validated state of all equipment and processes within their assigned area of responsibility.

• Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements.

• Provide direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained. Responsible for ensuring that all associates have what they need to complete their jobs safely.

• Responsible for special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area. Development of working relationships and strong communication links through all levels of the organization. Provides day-to-day support for the production floor to support completion of short-term projects.

• Provides leadership and establishes departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement.

• Builds and maintains a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments.

• Provide direction, evaluate and develop performance of direct reports

• Help in resolution of problems or introduction of changes in their respective areas

• Set performance standards and evaluate performance

• Provide career development and training advice and set short term and long term goals

• Provide regular feedback to direct reports on company and departmental operations

• Manages headcount and expenses in department to achieve site objectives and meet budget expectations.

The ideal candidate will possess a minimum 10-15 years’ experience in a cGMP controlled/pharmaceutical industry; including at least 5 years’ experience a regulated Quality environment is required.

Education:

• Bachelor’s Degree in Life Sciences, Engineering or Management

Required:

• Minimum of 7-10 years' experience in a management related role in a similar industry.

• Minimum of 5 years' experience in a regulated Quality environment is required.

• Thorough knowledge of CGMPs and regulatory requirements are required.

Candidate would have 5-8 years of managing people, vaccine, manufacturing, conjugation, process, Prenvac, Menige and Polysac experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Direct Staffing Inc