Audit Managing Manager

GENERAL POSITION SUMMARY:

The Audit Management Manager is responsible for the execution of audit and inspection management activities, including internal and external processes, contributing to and executing audit plans, supporting inspection readiness activities, and managing health authority (HA) inspections. This role involves designing and executing compliance audits across GxPs, CxOs, suppliers, and/or distributors through the development of a risk-based audit program designed to support activities across business functions. The role ensures adherence to applicable regulations, industry standards, and company policies, procedures, and quality standards as set forth in the Quality Management System.

KEY RESPONSIBILITIES:

- Contribute to the overall direction of the GxP audit program, ensuring performance and effectiveness in quality risk management and compliance with GxP regulatory requirements and guidance.

- Develop, maintain, and execute audit plans.

- Partner with and engage stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule.

- Manage outsourced audits.

- Enable the execution of GxP vendor qualification and requalification audits and mock inspection activities.

- Conduct internal and vendor audits of GxPs for CxOs, suppliers, and/or distributors.

- Engage in preparation, support, and follow-up activities for inspection readiness.

- Provide regulatory compliance support to cross-functional teams as requested.

- Participate in the collaborative review of impacted procedures, standards, and other documents.

- Review and analyze key performance indicator data and trends.

- Analyze risk and propose remedial, corrective, and/or preventive actions.

- Provide cross-functional support across the QA team.

- Identify and communicate risks.

- Support risk mitigation plan development and execution.

- Support due diligence and business development activities as requested.

- Provide cross-functional support across the Quality Assurance team and effectively partner with key stakeholders, business partners, and external organizations.

- Ability to travel 25-50% to conduct audits and support inspection activities.

KNOWLEDGE AND SKILLS:

- Good GxP Auditing Practices / GxP audit processes (focus on GMP/GDP).

- GxP quality systems.

- Regional/international knowledge of GxP regulations.

- CMC Manufacturing / Documentation (e.g., NDA, BLA Submissions).

- Investigation, root cause analysis, and effectiveness check processes, tools, and techniques.

- Change management and risk management principles and process knowledge.

- Global GMP regulations; 21 CFR Parts 210/211/610/820/11/1271 and applicable FDA guidelines, ICH guidelines, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines / Annexes, and applicable international equivalents.

- Deviation / OOS Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques.

- Risk Management Principles / Risk-based programs.

- Process Validation and Continuous Process Verification.

- Contamination Control Strategies.

- Strong leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.

- In-depth experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.

- Ability to independently lead cross-functional teams and represent the Quality unit.

- Ability to mentor and guide staff, skilled at transferring knowledge and teaching quality management skills.

- Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action.

- Demonstrated ability to work independently to provide QA advice for large, multifaceted projects.

- Demonstrated ability to evaluate quality matters and make complex decisions leveraging experience, advanced judgement, and the analysis/synthesis of a variety of information; able to work outside of precedent and take a new perspective on existing solutions.

- Strong experience successfully leading GxP audits and hosting health authority inspections.

- Strong experience with electronic document management and quality management systems (e.g., Veeva).

EDUCATION AND EXPERIENCE:

- Bachelor’s degree in a relevant field is required.

- Typically requires 6 years of relevant QA and Compliance experience or the equivalent combination of education and experience.

- Experience as a GxP generalist or in an applicable specialty area such as manufacturing, distribution, laboratory, or clinical practices.

- Knowledge of cGMP and GDP requirements governing oral drug products manufacturing and distribution practices.

- Strong experience as a lead auditor (certified auditor status preferred).