QA Consultant for CMO Management Small Molecules

K-Recruiting GmbH; Deutschland; Remote; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH is seeking a QA Consultant for CMO management in a 100% remote role. The position focuses on QA topics at CMOs, CAPA definition, document reviews (APQRs, PPQs, CPVs), and QAAs negotiation to ensure DS quality standards across suppliers.

The role requires 5+ years in pharma QA/QMS in GMP environments, strong English and stakeholder communication, and the ability to advise on regulatory inspections and audits.

Qualifikationen

• Experience in QA, QMS, and GMP-regulated environment.
• Experience managing CMOs or external suppliers is beneficial.
• 5+ years in the pharmaceutical industry.

Aufgaben

• Handle quality topics such as change control, deviations, and complaints for DS products at CMOs.
• Define CAPAs with CMOs and track timely implementation.
• Review and approve APQRs, PPQ reports, and CPVs.
• Prepare and negotiate QAAs with CMOs and ensure compliance.
• Provide technical QA guidance during inspections and audits for DS at suppliers.
• Identify quality risks at CMOs and escalate issues as needed.
• Advise local and global teams on quality needs for CMOs and share information with stakeholders.
• Support regulatory requests regarding GMP clearance or import licences; share knowledge across QA functions.

Kenntnisse

GMP/GDP knowledge

QA management

Communication

Diplomatic negotiation

Team collaboration

English proficiency

Ausbildung

Master's degree in natural or pharmaceutical sciences

Jobbeschreibung

QA Consultant for CMO Management Small Molecules (M/F/D)

Tasks

• Handle quality-related topics such as change control, deviations, and/or complaints related to the manufacturing of DS products at CMOs
• Define effective CAPAs together with the CMO and track timely implementation
• Review, evaluate, and approve documents such as APQRs, PPQ reports, and CPVs
• Prepare and negotiate QAAs with CMOs and ensure that CMOs work in accordance with DS QAAs
• Technical advice CMOs during authority inspections and audits on behalf of DS at different suppliers
• Identify quality risks at CMOs and elevate issues where necessary

Information Distribution within QA and Other Departments:

• Technical advice local and global teams and SMEs to identify and define quality needs for CMOs
• Share quality-related information from CMOs with regional and global stakeholders within the QA environment as well as in cross-departmental meetings
• Distribute information from stakeholders to the CMO and ensure timely implementation of agreed requirements

Support for Global and Regional QA Functions:

• Technical advice regional QA functions for regulatory requests regarding e.g. GMP clearance or import licence
• Share knowledge and expertise within QA and other functions to improve CMO management at DS

• In this role, you will engage in ad hoc and project-based technical exchanges with the Supply Chain, CMC, and Regulatory Affairs departments, as needed to ensure consistent supply to markets with products that meet our high quality standards at all times .

Qualification

• University/FH/Master's degree in natural or pharmaceutical sciences preferred 5 years + of experience in the pharmaceutical industry
• Experience specifically in Quality Assurance (QA), Quality Management Systems (QMS), and a GMP-regulated environment
• Experience with managing CMOs or external suppliers is beneficial

Competencies

• Excellent knowledge of international GMP/GDP regulations
• Expertise in small molecule manufacturing for Drug Substance and Drug Product
• Assertiveness and strong communication skills paired with a diplomatic attitude during negotiations
• Team player with high quality consciousness and a solution-oriented mindset
• Very good written and verbal communication skills in English
• Project management skills are desirable

Requirements

Start: 15.11.2026

Duration: 10 months

Capacity: 5 days per week

Location: 100% remote