Manager, Global Quality
2 months ago
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.
Reporting to the Sr. Director, Global Quality & Compliance, the Manager, Global Quality & Compliance:
- Identifies and develops global policies with the objective of ensuring good compliance practices.
- Sponsors a quality and compliance focused culture, collaborating closely with subject matter experts (SMEs) to identify and support continuous improvement plans.
- Supports implementation and/or recommends internal/external business or compliance options and best practices to improve processes, or services.
- Evaluates metrics to determine trends and opportunities for continuous improvements and liaises with global functions.
- Supports Endo’s strategy for compliance with emerging Quality related regulations and GMP trends from inspections and other regulatory activities.
- Has strong knowledge of the principles, concepts and theories of compliance and bio-sterile discipline
Key Accountabilities
Quality Documentation/Policies
- Independently develop Endo global policies and leads execution.
- Collaborate with subject matter experts (SMEs) and global Endo professionals to collect necessary information for documentation.
- Organize and structure policy content in a logical manner.
- Ensure that documentation complies with industry standards, regulations, and company guidelines.
- Coordinate the review and approval of documentation across Endo sites.
50%
Continuous Improvement & Risk Assessments
- Contributes to continuous improvement activities.
- Evaluates metrics to determine trends and opportunities for continuous improvement across Endo sites.
30%
Emerging Regulations
- Reviews emerging regulations, guidance documents, industry body communications, warning letters, market actions and other regulatory body activities of potential opportunity and recommends as necessary implementation via Corporate Policies and/ or Quality Management Systems.
20%
Total 100%
Qualifications
Education & Experience
- Minimum of a B.A./B.S. Degree in Science or related field OR
- 7 years experience in pharmaceutical/quality operations including direct quality management system participation.
- Prior experience working in a cGMP bio-sterile environment required.
- Existing experience writing policies and procedures, or general technical writing.
Knowledge
- Knowledge and understanding of quality processes, as well as cGMPs, SOPs and regulatory requirements.
- Continuous Improvement: Work with multiple improvement strategies such as Six Sigma and Total Quality Management to develop and monitor improvement processes within the global organization.
Skills & Abilities
- Strong computer/systems skills using Quality Management Systems, MS Office Suite, and/or Enterprise Resource tools (i.e., Trackwise, ComplianceWire, Veeva or similar).
- Strong technical writing and presentation skills.
- Organization: Must be highly organized to manage multiple tasks, timelines, and resources.
- Self-management: Able to prioritize tasks and manage themselves effectively to ensure deadlines are met.
- Critical Thinking: Applies structured data and risk analysis and critical thinking in all elements of their role.
- 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/accountability for own actions; Follows through on commitments.
- Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
- 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
- Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
- 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
- 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.
- 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
- Routine office work (sit/stand).
- Ability to lift 15 lbs.
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.
-
Global Quality Manager
3 weeks ago
Rochester, New York, United States Endo Full timeJob Title: Global Quality ManagerWe are seeking a highly skilled Global Quality Manager to join our team at Endo. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance across our global operations.Key Responsibilities:Develop and implement global quality policies and procedures to ensure...
-
Manager, Global Quality
1 month ago
Rochester, United States Endo Full timeWhy 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...
-
Manager, Global Quality
3 weeks ago
rochester, United States Endo Full timeWhy 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...
-
Quality Assurance Manager
2 weeks ago
Rochester, New York, United States Michael Page Full timeQuality Assurance ManagerThe Quality Assurance Manager will lead a team of quality inspectors in a fast-paced medical device manufacturing environment, ensuring compliance with quality standards and driving continuous improvement initiatives.This role involves overseeing quality control and documentation processes while adapting to the dynamic needs of the...
-
Quality Assurance Manager
3 weeks ago
Rochester, New York, United States Michael Page Full timeQuality Inspection ManagerMichael Page is seeking a Quality Inspection Manager to join our client, a global leader in surgical medical technology. This is a leadership opportunity reporting into the Director of Quality.About Our ClientOur client is a multinational company specializing in advanced plastics and composite materials. They focus on the design,...
-
Quality Assurance Manager
4 weeks ago
Rochester, New York, United States Michael Page Full timeQuality Inspection ManagerMichael Page is seeking a highly skilled Quality Inspection Manager to join our client, a global leader in surgical medical technology. As a key member of the quality team, you will be responsible for leading and managing the quality inspection process, ensuring compliance with industry standards and regulatory requirements.Key...
-
Quality Assurance Manager
3 weeks ago
Rochester, New York, United States Michael Page Full timeQuality Inspection ManagerThe Quality Inspection Manager will lead a team of quality inspectors in a fast-paced medical device manufacturing environment, ensuring compliance with quality standards and driving continuous improvement initiatives. This role involves overseeing quality control and documentation processes while adapting to the dynamic needs of...
-
Senior Manager, Global Credit and Collections
3 weeks ago
Rochester, New York, United States QuidelOrtho Full timeThe OpportunityQuidelOrtho is a world-leading in vitro diagnostics company, uniting the strengths of Quidel Corporation and Ortho Clinical Diagnostics. With a global presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most. Our culture prioritizes team member happiness, inspiration, and...
-
Sr. Manager, Global Credit and Collections
3 weeks ago
Rochester, United States QuidelOrtho Full timeThe Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...
-
Sr. Manager, Global Credit and Collections
4 weeks ago
Rochester, United States QuidelOrtho Full timeThe Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...
-
Sr. Manager, Global Credit and Collections
3 weeks ago
Rochester, United States QuidelOrtho Full timeThe OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...
-
Quality Assurance Manager
3 weeks ago
Rochester, New York, United States Greenlight Biosciences Full timeAbout GreenLight BiosciencesGreenLight Biosciences is a pioneering company that leverages RNA technology to create innovative agricultural solutions for farmers and beekeepers. Our mission is to develop highly effective products that protect honeybees and a range of fruits and vegetables, while degrading quickly in the environment.Job Title: QA...
-
Rochester, New York, United States Ortho Clinical Diagnostics Full timeThe OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a Senior Manager, Global Credit and Collections, to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions to meet the needs of our customers.Our CultureWe prioritize employee happiness and business success,...
-
Rochester, New York, United States Ortho Clinical Diagnostics Full timeThe OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are a global organization with over 6,000 employees, operating in more than 130 countries...
-
Global IT Director
3 weeks ago
Rochester, New York, United States Insero Talent Solutions Full timeJob Title: Global IT DirectorJoin Insero Talent Solutions in recruiting a Global IT Director for a leading manufacturing company.This role is responsible for leading the global IT team, spanning 6 locations in the US, Costa Rica, Ireland, and China. The successful candidate will direct, monitor, and evaluate global information systems, objectives,...
-
Medical Device Quality Assurance Manager
2 weeks ago
Rochester, New York, United States Michael Page Full timeThe Quality Inspection Manager will lead a team of quality inspectors in a fast-paced medical device manufacturing environment, ensuring compliance with quality standards and driving continuous improvement initiatives. This role involves overseeing quality control and documentation processes while adapting to the dynamic needs of the team and...
-
Rochester, United States Insight Global Full timeJob DescriptionJob DescriptionInsight Global is looking for a Senior Commercial Plumbing Construction Project Manager to sit for a plumbing and heating company in Rochester, New York. This company specializes in commercial plumbing projects for public institutions. The Commercial Plumbing Project Manager will oversee and manage all aspects of commercial...
-
Lead EMS Dispatch Team Manager
2 weeks ago
Rochester, New York, United States Global Medical Response Inc Full timeAt Global Medical Response, we are expanding our emergency communications team and seeking an experienced EMS Dispatch Team Manager to lead our operations. As a key member of our team, you will oversee daily dispatch activities, ensuring timely and efficient response to emergency calls. Your strong leadership skills and experience in emergency medical...
-
Quality Manager
1 week ago
Rochester, United States Oled Technologies LLC Full timeQUALITY MANAGEROverviewTechnology moves fast. We are looking for a Quality Manager to join our team who will focus on improving processes and sustaining high quality production in our fabrication and R&D labs. What You'll Do Every DayYou will ensure overall product and process quality in our Rochester division. Using both hands-on and theoretical knowledge,...
-
Quality Manager
1 week ago
Rochester, United States Oled Technologies LLC Full timeQUALITY MANAGEROverviewTechnology moves fast. We are looking for a Quality Manager to join our team who will focus on improving processes and sustaining high quality production in our fabrication and R&D labs. What You'll Do Every DayYou will ensure overall product and process quality in our Rochester division. Using both hands-on and theoretical knowledge,...
