Senior Quality Auditing Manager- Global Pharmaceutical CMO Dublin
Senior Quality Auditing Manager-Pharmaceutical-Dublin
The Senior Manager, Quality Auditing manages internal and external audits for 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 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 and support the company's vision and Key Values. Manage the internal and external auditing programs. Ensure department's expenditures remain on track and within the approved budget.
- External and internal auditing of suppliers/vendors and third parties for materials or services contracted by the company'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 and Experience:
- 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.
- 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.
- 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 behaviour.
- Walking/tour manufacturing sites/laboratories/packaging facilities/warehouses.
- Business Travel (25-35%).
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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