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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.

Job Description Summary

The Site Head of Quality oversees and assures overall quality/integrity of pharmaceutical products manufactured and distributed based on cGMP regulations and industry standards. The Site Head of Quality will promote and exhibit Endo’s vision, mission, values and leadership behaviors. The Site Head of Quality will establish and lead the improvement and implementation of Quality Operations Procedures and systems across the manufacturing site. This is a leadership role within the Quality organization that will work closely with stakeholders to assure the implementation of harmonized Quality Operations Systems that will maintain quality and work efficiently with Operations and Supply Chain, The Site Head of Quality will ensure that Global Quality Operations Standards are maintained in a compliant status versus current GXP, keeping pace with current and future changes in regulations. This role will drive sharing of best Operations practices across company locations – sharing of significant issues and lessons learned, and incorporating these into revisions of Global Quality Policies and Standards.

Job Description

Scope of Authority

Oversight of the Quality Operations Function at the site

Key Accountabilities

Accountability

Quality Operations

Decision maker for all quality decisions at the site

Lead investigations into deviations, OOS/OOT results, complaints, and critical quality issues, ensuring timely CAPA implementation.

Oversee supplier and contractor qualification, audits, and quality agreements.

Ensure robust document control, data integrity, and training programs.

Compliance

Ensure site readiness for **regulatory inspections** (e.g., FDA, EMA) and customer audits.

Serve as the quality representative during inspections, audits, and regulatory engagements.

Ensure timely resolution of audit observations and implementation of preventive measures.

Monitor changes in global regulations and proactively adapt site quality systems to maintain compliance.

Leadership

Serve as the primary quality authority for the site, ensuring that all activities comply with cGMP, ICH, FDA, EMA, and other applicable regulatory standards.

Lead the implementation and continuous improvement of quality systems and procedures to ensure product quality, safety, and integrity.

Collaborate closely with Operations, Supply Chain, and other functions to ensure harmonized and efficient quality processes across the site.

Foster a strong **quality culture** **,** emphasizing right-first-time execution, accountability, and continuous improvement

Lead, mentor, and develop the QA and Quality Systems teams.

Ensure that all quality staff receive appropriate training to remain current with cGMP and regulatory requirements.

Create a high-performance team environment, promoting collaboration and continuous learning

Qualifications

Education & Experience

+ Bachelor’s or advanced degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related life science field

+ 15+ years’ Quality Assurance / Compliance experience in pharmaceutical/ biotech industry, with at least five years in a senior leadership or site quality head role.

+ Deep expertise in **cGMP, FDA 21 CFR Parts 210/211, ICH Q10** **,** and other global regulatory standards.

+ Proven track record of successfully leading regulatory inspections and audits.

+ Strong experience with **quality systems** (CAPA, deviation, change control, risk management, etc.)

Knowledge

+ **Leadership & Vision:** Inspires and guides teams to achieve a culture of quality and excellence.

+ **Results Orientation:** Delivers high-quality results under tight deadlines.

+ **Change Management:** Navigates and leads teams through organizational and regulatory changes.

+ **Collaboration:** Builds effective cross-functional partnerships to achieve shared goals.

Skills & Abilities

+ Judgment - 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.

+ Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.

+ Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; takes calculated risks to accomplish goals.

+ Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.

+ 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 for own actions; follows through on commitments.

+ 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.

+ Project Management - Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.

+ Ability to influence, peers and other colleagues without direct reporting lines.

+ Ability to look beyond own area of expertise and responsibility and to understand the overall business impact of actions taken.

+ Ability to work in a dynamic environment and constantly redefine the scope of responsibilities in alignment with compliance and business needs.

+ Excellent writing and communication skills.

+ Ability to multi-task and prioritize work.

+ Demonstrable computer skills.

Physical Requirements

+ Ability to travel domestically or internationally as business needs dictate.

**_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._

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.

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.