Shire Jobs

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 Senior Manager, Enterprise Quality Auditing manages internal and external audits for Endo’s branded and Par Pharmaceutical business units and internal manufacturing sites. Coordination of communication with auditing stakeholders at the various business units and internal manufacturing sites, harmonization of systems and processes for integration of the auditing functions. This role is responsible for developing EQA operational procedures and performing/tracking quality audits to completion. The Senior Manager will liaise with auditing stakeholders at the Endo branded and Par Pharmaceutical business units and internal manufacturing sites for audits scheduling and harmonization of auditing processes and standards. This individual will ensure the department’s goals are met in support Endo’s vision and Key Values.

Job Description

Auditing 80%

• External and internal auditing of suppliers/vendors and third parties for materials or services contracted by Endo branded and Par Pharmaceutical’s internal manufacturing sites.

• Development, revision and implementation of Enterprise Quality Auditing procedures including audit techniques for data integrity assessments, policies, technical papers, risk assessments, business continuity plans and quality agreements.

• Responsible for communication with stake holders at the various business units and internal manufacturing sites.

• Responsible for the harmonization of auditing systems and processes to integrate the various business units.

• Authors, reviews and approves new procedures and/or revision of current procedures relevant to the Enterprise Auditing Quality standards/policies.

• Ensure audits are performed against domestic and international guidance and regulations as appropriate.

• Ensure the audit program is compliant with current regulations, internal procedures, requirements and timelines.

• Ensures timely and accurate communication, escalation of critical audit observations to management, partners, stakeholders, and staff.

Quality Metrics 10%

• Collection, collation and reporting of applicable Quality Auditing Performance Metrics.

People Development 10%

• Ensure the continuous development, coaching, and cross training of staff.

• Establish development plans.

• Oversee establishment of enhanced auditing training program, auditing standards and auditing development plans.

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.

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.