Nitcservices

Quality & Regulatory Posted August 20, 2026 at 2:55 AM

Company

simtrabps

Location

Halle, North Rhine-Westphalia

Type

Full-time

Commensurate with experience

Who are we looking for?

01 Proven experience in Quality Control/QA (Pharma/Biotech)

02 Deep understanding of cGMP & regulatory standards

03 Strong analytical skills & method expertise

04 Familiarity with quality systems (change control

05 OOT/OOS)

06 Experience with ICH guidelines

07 Proficiency in German & English

Product Manager (m/w/d) Quality Control Compliance (Temporary, 24 Months)

Company: Simtra

Category: Quality & Regulatory

Professional Overview

Simtra is a premier Contract Development and Manufacturing Organization (CDMO) with over 65 years of experience, dedicated to bringing sterile, injectable pharmaceuticals to market worldwide. Collaborating with more than 60 international clients, we focus on producing life-changing cancer therapeutics. Our mission is powered by over 2,000 employees across our three global sites, including our vital facility in Halle/Westfalen, Germany, where we manufacture critical medicines for various cancer and other life-threatening diseases.

We are currently seeking a highly motivated and detail-oriented Product Manager (m/w/d) Quality Control Compliance to join our team in Halle/Westfalen. This is a crucial 24-month temporary position where you will play a pivotal role in upholding the highest standards of analytical quality. Your work will directly ensure that all analyses of commercial contract products, active ingredients, and raw materials adhere strictly to pharmacopoeial guidelines, regulatory requirements, and customer specifications, contributing significantly to patient safety and product efficacy globally.

Key Responsibilities

• Develop and optimize test protocols, analytical methods, and specifications for the analysis of semi-finished goods, active pharmaceutical ingredients (APIs), excipients, and packaging materials.
• Evaluate and ensure strict compliance with cGMP guidelines during the analysis of products and starting materials.
• Assess and resolve complex analytical problems and discrepancies.
• Manage and process quality-related events, including complaints, change controls, deviations, OOT/OOS (Out of Trend/Specification) events, and anomalous findings.
• Plan, oversee, and evaluate ICH-compliant stability studies, compatibility studies, and specialized studies.
• Administer all Life-Cycle Management activities for approved pharmaceutical products.
• Review and approve relevant Quality Control documentation and reports.

Eligibility & Requirements

• Proven professional experience in Quality Control, Quality Assurance, or a related compliance role within the pharmaceutical or biotechnology industry, preferably in a CDMO environment.
• Comprehensive understanding and practical application of current cGMP guidelines, pharmacopoeial requirements (e.g., EP, USP), and international regulatory standards.
• Strong analytical problem-solving skills and experience with the development, optimization, and transfer of analytical methods.
• Demonstrated ability to manage and investigate quality incidents such as deviations, OOT/OOS results, and change controls.
• Familiarity with ICH guidelines, particularly those pertaining to stability studies and product life-cycle management.
• Proficiency in German and English, both written and spoken, is essential for effective communication in our international environment.