Quality Manager / Responsible Person

Pharmalliance Consulting Ltd.; Dublin; Hybrid; EUR 60,000 - 85,000; Part time

Job summary

Pharmalliance Consulting Ltd. seeks a detail-oriented Quality Manager / Responsible Person to support a cosmetics client in Ireland. This hybrid role combines remote work with 2-3 days on-site in City West, overseeing regulatory compliance, PIFs, CPSRs, CP NP notifications and QMS adherence.

The ideal candidate has extensive cosmetics regulation knowledge, strong organizational skills, and experience with CMOs, labeling, and post‑market surveillance. 6‑month contract with potential extension.

Qualifications

• Degree in science-based field (chemistry, biology, toxicology, pharmacology, cosmetics science) as required for RP duties.
• 3–5 years’ experience in quality, regulatory affairs or compliance within cosmetics/personal care industries.
• Deep knowledge of Regulation (EC) No. 1223/2009, ISO 22716 and HPRA expectations.
• Strong experience with PIFs, CPSRs, CPNP notifications, labeling and claims compliance.
• Familiar with complaint handling, recalls and post-market surveillance.

Responsibilities

• Act as Responsible Person (RP) under EC 1223/2009.
• Ensure each cosmetic product has a complete PIF and CPSR signed by a safety assessor.
• Submit and maintain CPNP notifications prior to market launch.
• Oversee labeling, language requirements and product claims compliance.
• Coordinate with CMOs, manage QMS, SOPs and quality documentation.
• Lead post-market activities including complaints handling and recalls.

Skills

Quality management

Regulatory affairs

Cosmetics compliance

PIFs CPSRs CPNP

Regulatory knowledge EC 1223/2009

ISO 22716

HPRA expectations

Labeling and claims compliance

Post-market surveillance

Education

Science-based degree

Job description

City West, Ireland | Posted on 18/09/2025

Pharmalliance offers expert support to pharmaceutical companies to maintain and increase quality compliance levels.

We specialize in cGMP Compliance, Remediation and Contamination Control and have a suite of services to help you stay compliant no matter what your stage of development.

Job Description

Duration: 6 months, contract, potential to extend.

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

PositionOverview:

PharmallianceConsulting Ltd is seeking a detail-oriented and compliance-driven QualityManager / Responsible Person (RP) to support a cosmetic manufacturing client.

In the roleyou will ensure the company’s cosmetic products meet all regulatory and qualityrequirements. The successful candidate will oversee product compliance withRegulation (EC) No. 1223 / 2009, HPRA requirements, and ISO 22716 CosmeticsGMP, including maintaining Product Information Files (PIFs), verifying CosmeticProduct Safety Reports (CPSRs), and managing product notifications in theCosmetic Product Notification Portal (CPNP).

The idealcandidate will have strong regulatory knowledge, excellent organisationalskills, and proven experience in quality management, labelling / claimscompliance, and coordination with Contract Manufacturing Organisations (CMOs).

Key Responsibilities

Legal & Regulatory Compliance

• Act as the Responsible Person (RP) as defined in Regulation (EC) No.1223 / 2009.
• Ensure each cosmetic product has a complete Product Information File (PIF) accessible at the company’s address.
• Verify that each product has a Cosmetic Product Safety Report (CPSR)signed by a qualified safety assessor.
• Submit and maintain product notifications in the Cosmetic ProductNotification Portal (CPNP) prior to placing products on the market.
• Ensure compliance of product labelling, claims, and languagerequirements.
• Ensure compliance with animal testing bans under Articles 17 and 19 ofthe Regulation.

Quality Management System (QMS)

• Oversee the company QMS in line with ISO 22716 Cosmetics GMP.
• 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.

Post-Market Responsibilities

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

Authority & Leadership

• Report directly to the Managing Director.
• Provide resources and guidance for regulatory and quality functionsacross the company.
• Maintain full authority to stop distribution or elevate processes wherenon-compliance or product-risk is identified.

Requirements

Qualification& Skills

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