Senior Manager of Manufacturing

Location: Mastic

Nature and Scope The Senior Manager of manufacturing will be responsible for managing and leading the day-to-day operations for the commercial aseptic manufacturing of drug and device products. The position scope can include any arrangement of the following departments:
Compounding, Equipment/ Component Preparation, Sterile Filling, Inspection and Packaging.

Ensure that supervisors provide daily oversight of their process to reinforce that department remains in compliance with all company SOPS, maintaining data integrity for all GMP processes and any department-specific requirements.  Additional compliance must be met for all regulatory requirements – FDA, OSHA, OFCCP, EPA, etc.

Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Strategic Focus Drives operational excellence in accordance with short and long-term organizational objectives and strategic focus through leadership & technical expertise for continuous development of people & team, quality expectations, compliance, safety, customer and financial goals. Provides leadership and technical guidance for all manufacturing personnel in order to foster a healthy environment and culture that is collaborative, innovative and which promotes operational excellence.

People / Team Development Responsible for providing key leadership, communication, and organizational management of both non-exempt & exempt personnel including, process supervisors.

Responsible for the hiring, development and coaching of employees in order to ensure optimal level of performance by all manufacturing personnel.

Ensure that prospective candidates, who are hired into the business, align with the strategic direction of the manufacturing organization and to help foster a learning organization that exhibits leadership, personal accountability, and a strong sense of purpose and urgency.

Commit to employee feedback and developmental processes through a communication plan, mentoring, technical acumen, and leadership development.

Operational Excellence Foster a culture of continuous improvement through employee selection, training and mentoring whilst focusing on operational efficiency and the elimination of “non-value added” activities.

Support plant-wide strategic plans, programs and activities.

Work collaboratively with inter- department and cross-functional teams and to act as a change agent whilst leading in a timely and productive manner.

Identify and follow up/lead opportunities that contribute to the improvement of current manufacturing processes and practices.

Manage and lead the daily manufacturing operations across a single or multiple value streams.

Quality, Compliance & Safety Responsible for assuring compliances with all regulatory requirements – FDA, OSHA, OFCCP, EPA, etc.

Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any department-specific requirements.

Ensures adherence to production schedules, while holding Supervisors and teams responsible for compliance with all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet scheduled attainment objectives.

Ensuring inspection readiness of all manufacturing areas.

Participates in inspections conducted by external / internal regulators and ensures the success of departmental audits.

Interfaces directly with customers and regulatory personnel during plant audits and inspections.

Is responsible for “on-time” completion of investigations, CAPA’s for major and critical deviations and QE’s.Reviews and approves Quality Reports, validation protocols and reports.

Manages Change Controls Complies with…