QA Manager & RP

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Job Description:

Job Summary

The Healthcare QA Manager leads the healthcare quality program UPS Healthcare in Dublin. They are also the Responsible Person (RP). This role ensures all operations meet regulatory and client requirements, supports new business implementation, oversees quality documentation and training, and manages audits, risk assessments, and compliance activities. The position supervises managers and staff and works closely with internal teams, clients, and regulatory agencies.

Key Responsibilities

1. Communication & Compliance

• Work with internal teams (Operations, IT, Business Development, etc.) to resolve quality issues and ensure regulatory compliance.
• Review and interpret policies, procedures, and regulations; guide teams and clients to meet required standards.
• Communicate with client QA teams and support business reviews or sales presentations.
• Interact with regulatory agencies and ensure required reports, documentation, and follow-ups are completed.

2. Quality Procedures & Documentation

• Write, update, and maintain SOPs and work instructions to meet regulatory requirements.
• Oversee document control processes (e.g., version control, numbering, controlled copies).
• Provide training for QA staff and internal teams on SOPs and regulatory topics.
• Coordinate with Corporate Compliance to keep procedures aligned and up to date.
• Ensure consistency in quality procedures across all locations.

3. People Management & Development

• Oversee performance management, staffing, and career development for QA team members.
• Identify training needs and development opportunities.
• Ensure goals and performance plans are documented and reviewed regularly.
• Provide coaching, feedback, and support to team members.
• Make staffing recommendations and ensure compliance with UPS performance expectations.

4. Risk Assessment

• Identify regulatory risks and requirements (e.g., product storage, controlled substances).
• Assess QA capabilities and recommend process improvements.
• Manage licensing and regulatory approvals for new business opportunities.
• Conduct gap assessments and implement corrective actions.
• Collaborate with legal and operational teams to reduce risks and ensure compliance.

5. Audits & Validation

• Lead the planning and execution of internal, client, and agency audits.
• Record audit findings and track corrective actions.
• Conduct facility, equipment, and system validations to ensure they meet required specifications.
• Support regulatory inspections and ensure follow-up activities are completed.

Required Knowledge & Competencies

Legal & Compliance

• Understands laws and regulations affecting healthcare products and supply chain operations.
• Identifies compliance issues and recommends corrective actions.

Risk Management

• Identifies and evaluates risks; develops appropriate mitigation plans.
• Monitors risk trends and supports business continuity planning.

Supply Chain Understanding

• Knows supply chain processes and can identify and solve issues related to product handling, movement, and storage.

Technical Writing

• Writes clear SOPs, reports, and technical documents; organizes information effectively.

Detail Orientation

• Produces accurate work, organized documentation, and precise records.

Incident Investigation

• Investigates deviations, incidents, or product issues; identifies root causes and corrective actions.

Education

• Bachelor’s degree required
  • Science preferred
  • Business acceptable
• Master’s degree preferred (Science or Business)

Experience & Certifications

• Experience: Required to be a Certified RP with HPRA
• Certification: Preferred (e.g., healthcare QA/RA industry certifications)

Industry Background (Preferred)

• Healthcare in