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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 Manager, Preparation Services, Bulk Manufacturing and D&C is responsible for operations utilizing hourly union operators that perform: 1) cleaning and sterilization of equipment and components for aseptic/sterile operations. Production includes a variety of drug and biological products, including Par branded, development and generic as well as contract customer products; operations conducted while meeting department quality, safety, delivery and productivity objectives. Establishes objectives for the department and metrics reporting. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Responsible for oversight of group leaders and supervisors in Preparation Services. Ensures compliance with documentation reviews, training, and change control. Initiates, and/or reviews and approves department standard operating procedures, investigations, and change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives.

In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Job Description

Scope of Authority

Manager, Preparation Services, Bulk Manufacturing and D&C at Rochester, MI manufacturing plant; responsible for 4-6 supervisors and personnel across 2-3 shifts; budgetary responsibility $3M; spend signing authority up to $10K/PO. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice. Significant equipment includes: Sterilizers, Isolators, Washers, etc.

Key Accountabilities

Operations

• Runs operation to meet or exceed delivery performance objectives for product or projects

• Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation

• Ensure all equipment is working properly

• Ensures equipment cleaning techniques are qualified/achieved

• Maintains a safe work environment

• Backs up Supervisor duties and responsibilities as needed

Compliance

• Understands and adheres to good documentation practices (GDP)

• Drives Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure

• Confidently demonstrates knowledge and executes proficiently in at least one QMS area: deviation management and/or change control

• Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure. Approves investigations and/or change control plans

• Counsels, trains, and develops Group Leaders, Supervisors, and union colleagues for efficient performance; creates an atmosphere of team effort and open communication

• Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes

• Approves maximo work orders

• Creates, reviews, approves, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety.

• Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance.

• Follow and comply with company Safety policies and OSHA Regulations

• Participates in development and maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.

Supervisory

• Reports daily production updates at daily Huddle or SMART meetings

• Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations

• Direct manpower as needed, resolve conflict and assume all aspects of leadership including oversight of disciplinary actions

• Monitor performance and attendance of all Prep Services personnel

• Makes personnel utilization decisions and PTO requests based on total queue, backlog, and resource capacity.

• Assigns projects for continuous improvement

• Requests equipment and facility repairs, or modifications

• Understands and complies with Union Agreement

Leadership

• Develops and reports departmental metrics

• Participates in recruitment, selection, promotion, and retention of personnel

• Reviews operational performance; drives improvement opportunities

• Recognize and reward employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee morale

• Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook

• Identify developmental needs of others; provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills

• Provide regular coaching and performance feedback to employees in addition to conducting annual performance reviews. Recognize and implement performance improvement plans when needed in consultation with Human Resources Business Partner

• Troubleshoots or resolves issues impeding department objectives/deliverables; proactively demonstrates the ownership to achieve

• Interfaces with suppliers of equipment or products and area consultants/experts

• Conducts/supports CMO audits or regulatory agency inspections

Qualifications

Education

• Required: B.A. /B.S. Degree in Science, Business or related field or significant experience

• Desired: B.A. /B.S. Degree in Science and/or Management degree

Experience

• Required – 5 years minimum in a supervisory role in Operations, or Quality department with increasing levels of responsibility or equivalent

• Desired – 5 years in an Operations supervisory role or equivalent experience with QMS (deviation/change control) and project management

Knowledge

• Knowledge of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite, Kronos, Maximo, etc.

• Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA

Skills and Abilities

To perform the job successfully, an individual should demonstrate the following competencies:

For internal candidates: meets or exceeds expectations for competencies outlined in the Supervisor and Sr. Supervisor Preparation Services Job Descriptions in addition to the following:

• Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities

• Change Management – Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results

• Managing People – Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self 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

• Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness

• Cost Consciousness – Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources

• Judgement – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions

• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention

To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:

• Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments

• Visionary Leadership – Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates

• Delegation – Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results

• 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

• Business acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals

• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce

• 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

• Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization's strengths and weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions

Physical and Work Requirements

• Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5

• Stand, Walk, Sit, Talk and/or Hear

• Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.

• Specific vision abilities required by this job include close vision

• Frequently working near or exposed to moving mechanical parts

• The noise level is moderate

• Occasional exposure to fumes, airborne particles, toxic or caustic chemicals

• Work environment is a production/manufacturing plant

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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.

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.