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.
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 - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
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 - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
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
20%
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.
25%
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
25%
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
30%
Total
100%
Qualifications
Education and Experience
Minimal acceptable level of education, work experience and certifications required for the job
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
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
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
_Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, ne
