Senior Manager, Enterprise Quality Auditing
Enterprise Quality Auditing (EQA)
Direct Reports (list)
2 GMP Auditors (various levels)
Reports to (title)
Senior Director, Enterprise Quality Auditing
Job Summary - a concise overview of the job
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.
All incumbents are responsible for following applicable Division & Company policies and procedures.
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.
- Manage the internal and external auditing programs.
- Ensure department’s expenditures remain on track and within the approved budget.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
- 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.
- Collection, collation and reporting of applicable Quality Auditing Performance Metrics.
- 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.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Minimum of a Bachelor of Science or equivalent relevant industry experience, Masters in Life Sciences or Science degree is preferred.
- 12+ years of experience in the pharmaceutical/biotechnology industry.
- 10+ years of experience performing GxP audits.
- Quality management, demonstrated experience in establishing and overseeing Quality Systems.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Knowledge of FDA GXP, ICH regulations and domestic and international guidelines and industry best practices.
- In-depth knowledge of cGMPs, GDPs, GLPs, domestic and international regulatory inspections and interaction with the domestic and international regulatory agencies.
- Deep understanding of the domestic and international pharmaceutical industry with solid working foundation within the regulatory environment, organization, and structure.
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.
- Proficient in the use of current office software to enable accomplishments of the objectives.
- Influence and motivate other departments to take the lead for communicating, monitoring and ensuring Quality and Compliance within their areas.
- Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups; ability to communicate with technical and non-technical colleagues.
- Organize, prioritize work and deliver on the required deadlines or commitments.
- Establish and maintain effective business relationships, both internally and with the external partners such as CMOs, Suppliers and Regulatory agencies.
- Strong managerial skills.
- Strong writing and communication skills.
- Achieve Risk Based GMP Outcomes.
- Detail oriented and ability to translate data into information.
- Lead, manage and participate in teams with shared responsibility for outcomes and decision-making.
- Self-motivated to learn from industry groups, current literature and emerging regulatory requirements and/or expectations
- Demonstrates exceptional commitment to ethical behavior.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Walking/tour manufacturing sites/laboratories/packaging facilities/warehouses.
- Business Travel (25-35%).