Director, Sterile Filling Operations

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

The Director of Operations at the Rochester MI facility leads the establishment, implementation, maintenance and execution of: aseptic/sterile filling of liquid, suspension, or lyophilized product in plastic / glass bottles, vials or syringes. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives and sustain site’s positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance. The individual must have the ability to coordinate work between functions to ensure alignment with overall site Vision, Mission and Execution Strategy.

Job Description

Key Accountabilities

• Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
• Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
• Maintains proper staffing and training levels to meet requirements.
• Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.
• Sets priorities to meet internal cycle times and delivery schedules.
• Assure adequate maintenance of department machinery and supplies.
• Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.
• Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations
• Develops and maintains a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations. Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
• Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement)
• Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Performs 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.
• Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
• Interviews, hires, and ensures training of employees; plans, assigns, and directs work; appraises performance; rewards and redirects employee’s activities; addresses complaints and resolves problems.
• Develops and trains 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.
• Secures effective training programs or resources thru partnership with the WorkForce Development Team to support compliance with CFR, OSHA regulations, and manufacturing execution demands.
• Assures compliance with procedures, cGMP’s regulations, safety, and contract obligations. Reviews documentation produced by management for violations of company policy; recommends disciplinary actions.
• Number of exempt employees - direct: 6-8; indirect: 15-25
• Number of Hourly employees - indirect: 75-125
• Establishes expectations, drives accountability & influences effective team building and team work.
• Creates an atmosphere of team effort, open communication and inspirational shop floor management.
• Interacts productively with peers across all site work streams.
• Leads operations managers, supervisors, and hourly staff.
• Develops cooperative relationships with contractual bargaining agreement leadership team and colleagues
• Meets site objectives in compliance, quality, transformation, employee learning & development, and financial areas.
• Supports capital planning initiatives to ensure site remains compliant with local, state and federal requirements.
• Sponsors Operational Excellence Program (OEP) improvements as development opportunities for all staff.
• Manages special projects as requested/assigned by Executive Team.
  
  

Qualifications

Minimal acceptable level of education, work experience and certifications required for the job

• Direct parenteral manufacturing/quality experience preferred.
• Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business
• Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations inclusive of programs to support ongoing personnel development.
• 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.

• 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)
  
  

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions. Excellent communication skills, including the ability to speak clearly and persuasively in all situations, listen and gain clarification, respond well to questions and write clearly and informatively
• Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Skilled and Determined - Committed to removal of the eight non-value-adding wastes: Overproduction: Producing product or operating processes where orders do not exist; Waiting: Workers standing around and waiting for the next process step or a process to commence; Unnecessary transport: Carrying Work In Process (WIP) long distances and/or in a “back and forth” repeated manner; Overprocessing: Taking unneeded steps to process the product; Excess inventory: Excess Raw Material, WIP, or Finished Product leading to exaggerated cycle times, obsolescence and storage costs; Unnecessary movement: Any wasted motion of workforce to produce product or operate a process; Defects: Production of defective and/or non-usable products; Unused employee creativity: Loosing time, ideas, skills and improvements by not engaging and/or listening to our employees. Passion for Right First Time (RFT) Processing
  
  

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Stand, walk, sit, lift, talk and hear in office, laboratory and manufacturing work areas
• Frequent walkthroughs of shop floor operations
  
  

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.