Description
Nordic Cold Chain Solutions is one of the world’s largest suppliers of cold chain products. Our product lines include gel refrigerants and insulated shipping containers used in strategic logistics for the pharmaceutical, specialty food and the meal kits industry. We currently have an opening for a Senior Quality & Compliance Manager. Ideal candidates will be resourceful and self-motivated individuals, who have a strong work history in quality assurance management positions within a manufacturing environment. Also, candidates must have great communication skills, work well under pressure and possess proven leadership abilities.
Responsibilities:
Quality Management System (QMD) Ownership – lead ISO 9001:2015 and GMP compliance systems: maintain procedures, CAPA, audits
Change Management (MoC) Integration – Build and manage formal MoC workflow with risk assessment and signoff (Ops/EHS/ENG)
Validation & Qualification (IOPQ) – Partner with Ops/Lab for IQ/OQ/PQ documentation and CAPA closure
Supplier & Customer Audits – Lead all internal/external audits, CAPA responses, and audit readiness
Training & Competency Programs – Manage training matrices for GMP, change control, documentation
Document Control System – Ensure controlled forms, versioning, SOPs via SharePoint or QMS
Pharma Client Interaction – Liaise directly with Pharma quality teams for supplier approval, deviations
Continuous Improvement (Quality CI) – Trend quality KPI’s (defects, deviations, complaints); drive CAPA improvements
Requirements
Required Shills and Competencies:
ISO 9001 & GMP Systems – Proven track record implementing and maintaining ISO 9001 / 13485 / GMP-compliant QMS
Pharma / Life Sciences Experience – experience supporting validation, batch release, or supplier audits
Change Control / MoC Integration – Practical ability to create workflows that bridge Ops and Quality
Audit Leadership – Hands-on audit prep and interface with FDA / OSO / Pharma auditors
CAOA / Deviation Management – Mastery of risk-based CAPA systems and root cause analysis
Training & Documentation Systems – Strong documentation discipline: LMS or QMS software familiarity
Technical Background – Science, Engineering, or Quality Systems degree
Leadership / Soft Skills – Collaborative, confident communicator, capable of coaching non-degreed managers
