Director of Sterile Filling Operations

6 days ago

Rochester, Michigan, United States Endo International Full time
Job Description

At Endo International, we are seeking a highly skilled and experienced Director of Sterile Filling Operations to lead our sterile filling operations team. As a key member of our operations team, you will be responsible for ensuring the efficient and effective production of sterile products.

Key Responsibilities
  • Lead the establishment, implementation, maintenance, and execution of aseptic/sterile filling of liquid, suspension, or lyophilized product in plastic/glass bottles, vials, or syringes.
  • Direct production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
  • Oversee the execution of commercial production to meet patient, quality, business, and financial objectives.
  • Maintain proper staffing and training levels to meet requirements.
  • Provide management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.
  • Set priorities to meet internal cycle times and delivery schedules.
  • Assure adequate maintenance of department machinery and supplies.
  • Establish and drive expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.
  • Participate and develop long-term strategies and risk management programs that increase the compliance, efficiency, and effectiveness of operations.
  • Develop and maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state, and federal environmental, health, and safety regulations.
  • Participate in safety meetings, investigate accidents, expect proper PPE and industrial hygiene controls, and take appropriate corrective actions to eliminate hazardous conditions.
  • Promote a quality and compliance-focused culture which embraces RFT (right first time) and CI (continuous improvement).
  • Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.).
  • Perform assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance, and safety.
  • Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.
  • Manage audits and inspections by regulators, corporate office, and contract customers by escorting and facilitating information sharing, document review, and response commitments.
  • Direct change controls related to processes, equipment, documentation, and safety practices in accordance with Quality System requirements.
  • Interview, hire, and ensure training of employees; plan, assign, and direct work; appraise performance; reward and redirect employee's activities; address complaints and resolve problems.
  • Develop and train managers & supervisors for more effective performance in current assignments as well as future leadership roles to meet on-going personnel development and succession planning objectives for continued business continuity.
  • Secure effective training programs or resources thru partnership with the WorkForce Development Team to support compliance with CFR, OSHA regulations, and manufacturing execution demands.
  • Assure compliance with procedures, cGMP's regulations, safety, and contract obligations.
  • Review documentation produced by management for violations of company policy; recommend disciplinary actions.
Requirements
  • Bachelor's/Master's degree from an accredited college or university with a major in Science, Packaging Engineering, or Business.
  • Direct parenteral manufacturing/quality experience preferred.
  • Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality, and/or Compliance Management.
  • Emphasis on team building, problem-solving, and employee development inclusive of succession planning.
  • High level of proficiency in adult education and training, and group presentation.
  • Must be familiar with different approaches to staff and management development using various delivery systems.
  • Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs, and presentations.
  • Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Preferred Qualifications
  • Microsoft Office Suite, Quality Management Systems (QMS: Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS) CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes).
  • Leadership attributes, skills, abilities, or behaviors that may be enterprise, functional, or job-specific e.g. coaching, negotiation, calibration, technical writing, etc.
What We Offer

At Endo International, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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