Job Information
Endo International Manager, Process Excellence - Deviations in Rochester, Michigan
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 of Process Excellence for Deviations plays a critical role in ensuring quality, compliance, and continuous improvement within our organization. This position oversees a team of investigators driving resolution of deviations, as well as the creation and implementation of CAPAs to prevent recurrence as well as procedures for implementation of best practices. The manager collaborates with cross-functional teams to drive timely resolution and foster a compliance-focused culture.
All incumbents are responsible for following applicable Division & Company policies and procedures.
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.
Process Excellence management responsibilities primarily within a single site. Position has 6 direct reports.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Investigation Program Management
Develop/Manage the Investigation Program :
Develop and implement an Investigator Certification Program.
Develop/Introduce tools to achieve Root Cause Analysis.
Incorporate Concepts of Quality by Design into Product Lifecycle.
Report Metrics at Tier Meetings
30%
Quality Management System
Possess a deep understanding of Quality Management Systems (QMS), including change management, deviation handling, and CAPA processes.
Collaborate with Quality Assurance and other departments to maintain compliance with regulatory requirements.
10%
Technical Writing & Documentation
Provide guidance and oversight to the Operations Support Technical Writer.
Review and approve technical documents related to deviations, CAPAs, and process improvements.
Ensure clear, concise, and accurate documentation of investigations and corrective actions.
40%
Cross-Functional Collaboration
Serve as a liaison between departments, fostering effective communication and collaboration.
Work closely with manufacturing, quality, and regulatory teams to align processes and drive improvements.
20%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
BS + min. 10+ years’ experience in a pharmaceutical environment.
5+ years’ experience in Supervision of others.
Prior experience leading cross-functional teams.
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.
- Expert knowledge of cGMPs, FDA/EMA requirements.
Skills
&
Abilities
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.
Advanced Microsoft Office Suite skills.
Excellent communication skills: written, verbal, facilitation, decision making, collaboration and conflict management
Demonstrated influencing skills and the ability to effectively influence key stake holders
Strong organizational skills, attention to detail and ability to multi task
Visionary Leadership - Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
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.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals
Adaptability - Adapts to changes in work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
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.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Office environment.
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.