Senior Manager, Operations, Manufacturing Administration, Michigan-Rochester
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide. For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89. Learn more at www.endo.com.
The Sr. Manager, Operations is responsible for oversight of more than one operational department utilizing union personnel to process a variety of drug and biological products, including Par branded, development & generic, as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Directly responsible for more than one operating manager. Departments may include dispensing, bulk manufacturing, primary filling, lyophilization and/or terminal sterilization, inspection, labeling, and packaging. Assures the facilities, equipment, supervision, and staff are properly trained. Establishes objectives for the department and metrics reporting. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Reviews and approves department standard operating procedures, investigations, and change controls to support business and quality objectives. Establishes & maintains cooperative cross-functional relationships with peers and leadership in Quality, 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.
Sr. Manager of operations at Rochester, MI manufacturing plant; directly responsible for more than one manager and their direct reporting structures (personnel across 2-3 shifts); Budgetary responsibility ~$5M; spend signing authority up to $5K/PO. Significant equipment may include: Scales, Tanks, Sterilizers, Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Isolators, Cappers, Lyophilizers, Terminal Sterilizers, manual, semi-automated, and automated inspection equipment, labelers, cartoners, and casepackers.
ROLE AND RESPONSIBILITIES:
+ Manages oversight of production in more than one operating area, across three shifts, to meet or exceed delivery performance objectives; may include: Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
+ Elevates obstacles preventing execution of production.
+ Develops, reports, and communicates departmental metrics.
+ Supports developmental and technical transfer production activities.
+ Establishes and drives expectations for production scheduling & reducing non-value-added waste.
+ Reports daily production updates to cross functional support groups and Operations Support Manager.
+ Manages operational area Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures, Risk Assessments etc.) to on-time closure; reviews and approves deviations, protocols, studies, reports, documentation, and/or change control.
+ Follows and complies with company Safety policies and OSHA Regulations; develops and maintains 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.
+ Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.
+ Assures operating areas comply with all procedures, GMP regulations, safety, and contract obligations; follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook.
+ Counsels, trains, & develops management; creates an atmosphere of team effort & open communication.
+ Develops and trains managers to meet on-going personnel development and succession planning objectives for business continuity.
+ Directs manpower as needed, between areas, based on production demand and resource capacity.
+ Resolves conflict and assume all aspects of leadership including oversight of and recommendations for disciplinary actions.
+ Understands & complies with CBA (contract bargaining agreement); develops cooperative relationships with CBA leadership team and colleagues.
+ Creates an atmosphere of team effort, open communication and inspirational shop floor management.
+ Leads operations managers, supervisors, and hourly staff.
+ Interacts productively with peers across all site work streams.
+ Drives operational performance & improvement opportunities.
+ Leads in the selection, promotion, & retention of personnel; maintains proper staffing and training levels to meet operating requirements.
+ Recognizes and rewards employees that consistently perform at high levels or go above and beyond their required job duties to maintain a high level of employee morale.
+ Identifies developmental needs of others; provides coaching, mentoring, and encouragement to help others to improve their knowledge or skills.
+ Provides regular coaching and performance feedback to employees in addition to conducting annual performance reviews; recognizes and implements performance improvement plans when needed in consultation with Human Resources Business Partners.
+ 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.
Education & Experience
+ B.A. or B.S. Degree in Science, Business or related field or significant experience is required.
+ Minimum of 5 years’ experience as a Manager in parenteral operations, or Quality department with increasing levels of responsibility or equivalent is required.
+ B.A. or B.S. Degree in Chemistry, Microbiology, Engineering and/or Management degree is desired.
+ Minimum of 5 years’ experience as a Manager in Sterile Filling or equivalent experience with QMS (deviation/change control) and project management is desired.
+ 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 & Abilities
+ 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.
+ 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 & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
+ Requires periodic garbing in/out of environmentally controlled areas up to ISO Grade 5.
+ Stand, Walk, Sit, Talk and/or Hear.
+ Specific vision abilities required by this job include close vision.
+ May work 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.
+ Afternoon shift premium is 10% (non-union positions only)
+ Midnight shift premium is 15% (non-union positions only)
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled