Corporate Quality Auditing Senior Specialist

Corporate Quality Auditing Senior Specialist

Location:

Parma, Italy | Date: 9 May 2026 | Job Type: Direct Employee |

Contract:

Permanent

Job Summary
Responsible for independent GMP/ISO audits, supplier qualification and monitoring of global suppliers, ensuring compliance with Chiesi quality standards and regulations.
Responsibilities

Carry out GMP/ISO audits of GMD contractors in full autonomy
Draft quality agreements
Ensure supplier qualification and validation according to GxP requirements and Chiesi quality standards
Ensure the quality of global suppliers and monitor their quality performance
Collaborate in internal/external audit activities: planning and updates, issue annual audit plans, preparation of materials and documentation, draft audit agenda, contact suppliers to be inspected
Conduct audits in Europe and worldwide, draft audit reports in English, check proposed corrective actions, monitor progress and closure of corrective actions, verify effectiveness of corrective actions, prepare synoptic tables on audit status for management review
Participate in drafting and maintaining sector operating procedures: qualification, validation, maintenance, quality risk management, instructions, templates, user guides for GxP suppliers and service providers, procedures related to GxP audits, review supply chain map and quality agreements
Investigate non‑conformities of materials in acceptance, collaborating with internal representatives and global suppliers to promote corrective actions
Evaluate change controls related to suppliers, CMO, GxP service providers: assess impacts on qualification, audits, quality agreements, validations, supporting documents; support pre‑ and post‑implementation actions
Maintain quality statements from GxP suppliers (e.g., TSE/BSE)
Conduct supplier validation including preliminary supplier evaluation, evaluation of product quality with company functions involved in DLC/Procurement, draft validation reports for raw materials and packaging materials suppliers, update validated suppliers’ tables periodically
Evaluate contractors qualitatively and collaborate with QA/AUH to calculate supplier quality scores

Qualifications

Degree in scientific disciplines such as Pharmacy, Chemistry, Biology or similar
Minimum 5 years experience auditing sterile and biological medicinal products
Good spoken and written English
Knowledge of national and international pharmaceutical legislation (DL 219, Eudralex Vol IV, 21

CFR parts 210, 211)
Expertise in pharmaceutical products manufacturing and control, sterile and biotechnology products
Experience in auditing practices and supplier quality assurance
Preferred:
Auditor qualification or QP certification (ISO 9001:2015, Corporate Quality Systems evaluator, GMP Auditor certificates, or training from specialized companies such as APIC, PDA, ECA)

Soft skills:

customer orientation, communication, proactiveness, goal orientation, quality orientation

Benefits

Permanent contract at Parma with competitive salary, performance bonuses and benefits benchmarked against market
Comprehensive healthcare programs, work‑life balance initiatives, robust relocation support, flexible working arrangements and remote work options
Training and development opportunities, tax assistance for foreign colleagues

Equal Opportunity Statement
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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