Quality Manager / Responsible Person

Job Description

Duration: 6 months, contract, potential to extend.

Location: Remote with 2 3 days of office attendance in City West.

Position Overview: Pharmalliance Consulting Ltd is seeking a detail oriented and compliance driven Quality Manager / Responsible Person (RP) to support a cosmetic manufacturing client. In this role you will ensure the company's cosmetic products meet all regulatory and quality requirements. The successful candidate will oversee product compliance with Regulation (EC) No. 1223/2009, HPRA requirements, and ISO 22716 Cosmetics GMP, including maintaining Product Information Files (PIFs), verifying Cosmetic Product Safety Reports (CPSRs), and managing product notifications in the Cosmetic Product Notification Portal (CPNP).

Key Responsibilities 1. Legal & Regulatory Compliance

• Act as the Responsible Person (RP) as defined in Regulation (EC) No. 1223/2009.
• Ensure each cosmetic product has a complete PIF accessible at the company's address.
• Verify that each product has a CPSR signed by a qualified safety assessor.
• Submit and maintain product notifications in CPNP before placing products on the market.
• Ensure compliance of product labeling, claims, and language requirements.
• Ensure compliance with animal testing bans under Articles 17 and 19 of the Regulation.

2. Quality Management System (QMS)

• Oversee the company QMS in line with ISO 22716.
• Maintain SOPs, training, and controlled quality documentation.
• Manage supplier and CMO approval, qualification, and quality agreements.
• Monitor deviations, CAPAs, and change controls.
• Review and approve product batch release documentation.

3. Post-Market Responsibilities

• Act as the primary contact for HPRA and other competent authorities.
• Coordinate complaint handling, adverse event monitoring, and recalls.
• Maintain traceability and distribution records to enable rapid product withdrawal if necessary.
• Ensure periodic product safety reviews and continuous compliance monitoring.

4. Authority & Leadership

• Report directly to the Managing Director.
• Provide resources and guidance for regulatory and quality functions across the company.
• Maintain full authority to stop distribution or accelerate processes where non compliance or product risk is identified.

Requirements

Qualification & Skills:

• Degree in a science based discipline (e.g., chemistry, biology, toxicology, pharmacy, cosmetic science or related life sciences discipline) - required by EC 1223/2009 for RP duties.
• Minimum 3-5 years of experience in quality, regulatory affairs, or compliance within cosmetics, personal care, or related industries.
• In depth knowledge of Regulation (EC) No. 1223/2009, ISO 22716, and HPRA expectations.
• Strong experience with PIFs, CPSRs, CPNP notifications, labeling, and claims compliance.
• Familiarity with complaint handling, recalls, and post market surveillance.
• Excellent organizational, communication, and decision making skills.
• Full time position with occasional on site visits to office/CMOs/vendors and attendance during HPRA inspections as required.
• Flexible working hours with availability during EU business hours.
• Competitive salary commensurate with experience.