Senior Quality & Compliance Manager at Nordic Cold Chain Solutions

Hatfield Township, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

0.0

Posted On

17 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ISO 9001, GMP Systems, Pharma Experience, Life Sciences Experience, Change Control, Audit Leadership, CAOA Management, Deviation Management, Training Systems, Documentation Systems, Technical Background, Leadership Skills, Communication Skills, Quality Management, Continuous Improvement, Risk Assessment

Industry

Packaging and Containers Manufacturing

Description

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

Responsibilities

The Senior Quality & Compliance Manager will lead the Quality Management System and ensure compliance with ISO 9001:2015 and GMP standards. Responsibilities include managing audits, training programs, and continuous improvement initiatives.