Quality Manager / Responsible Person

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.