Senior Quality Manager Compliance

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 Snr Manager, Compliance and Quality Systems has primary responsibility for site Quality Systems and Compliance. The Snr Manager will develop the existing team working in a collaborative environment. They will work with other Quality and the cross functional leaders (Supply Chain, Quality Operations, Regulatory Affairs, Strategic Sourcing, and Technical Operations) to develop a culture of accountability, empowerment, continuous improvement, customer focus, involvement, collaboration, and development of all people within the Value Stream.
This position will focus on the maintenance and improvements to systems to assure compliance to cGMP’s meeting FDA and company goals in an efficient manner. They will oversee all assigned Compliance systems, including but not limited to: leading site inspections; customer and internal audits; Supplier management program (for suppliers, service providers, contract labs, etc.); product complaint oversight, change control management and CAPA management. The candidate will also review current practices for areas of improvement and lead the projects to complete these actions.

Job Description

Key responsibilities include

Quality Systems Management

• Primary responsibility for multiple quality systems in support of commercial and development activities.
• Quality Systems may include but are not limited to: Event management, Change Control, Risk Assessments, Complaints, Document Control, Annual Product Reviews, Annual Reports, Validation Documentation oversight.
• Develops and maintains key Quality metrics.
• Responsible for on-time closure of QMS assignments.
• Collaborates with site wide activates for QMSR changes

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Leadership

• Manages and prioritizes workloads and projects to ensure effective and efficient completion of departmental objectives
• Drives performance through on-time closure of QMS activities.
• Troubleshoots or resolves issues impeding department objectives/deliverables; demonstrates the ownership to achieve.
• Consistently communicates; creates an atmosphere of team effort & open communication. Reports quality updates at tier meetings
• Keeps director informed of events; elevates as needed.
• Develops, maintains and mentors a staff of QA professionals.

• Selects, develops, motivates, and retains qualified quality operation staff to effectively carry out quality operation functions within the Value Stream Organization (VSO), and provide for the continuity of managerial and specialized skills.
• Recognizes and rewards employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee morale. Identifies the developmental needs of others and provides coaching, mentoring, and encouragement to help others improve their knowledge or skills.
• Communicates new regulations, Regulatory/FDA initiatives, and current Quality & Compliance approaches

Compliance

• Supporting role and a primary FDA interface for site inspections involving the above mentioned areas.
• Assures systems exist and function to meet all regulatory requirements.
• Manages the regulatory inspection program.
• Manages the Customer and internal audit programs.
• Hosts or provides assistance in regulatory, customer and corporate inspections/audits.
• Evaluates inspection/audit responses and corrective action plans and, if applicable, tracks corrective actions to closure.
• Performs Internal Audits, as needed.
• Manages supplier audit schedule adherence.
• Oversees and approves the Annual Report Program
• Maintains Quality Agreements.

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.