GMP Compliance Manager (Quality Specialist)

Solvias; Kaiseraugst; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Solvias is seeking an Operations Compliance Manager to partner with Operations leadership in sustaining GMP quality and compliance. You will lead investigations, support quality systems, and drive sustainable compliance improvements across cross-functional teams.

The role focuses on strengthening quality culture, inspection readiness, and operational excellence while maintaining robust documentation and readiness for audits.

Qualifikationen

• Experience in GMP-regulated environments with quality systems and investigations.
• Strong root-cause analysis, CAPA development and tracking.
• Ability to collaborate across functions and document precisely.

Aufgaben

• Lead investigations of quality events and deviations.
• Facilitate root-cause analyses and CAPA definitions and tracking.
• Ensure GMP-compliant documentation and quality records.
• Support SOP maintenance and change controls across functions.
• Assist audits and implement resulting action plans.
• Drive quality culture and inspection readiness within Operations.

Kenntnisse

Quality investigations

CAPA management

Root cause analysis

Cross-functional collaboration

Analytical thinking

Communication

Documentation

Ausbildung

Bachelor's or higher in Life Sciences, Chemistry, Pharmacy

Tools

Electronic Quality Management System

Jobbeschreibung

Job Description

As an Operations Compliance Manager, you will support Operations in maintaining and continuously improving quality and compliance standards within a GMP-regulated environment.

You will act as a key partner to the Operations Leadership Team by facilitating investigations, supporting quality systems, and driving the implementation of sustainable compliance measures. Through close collaboration with cross-functional teams, you will help strengthen quality culture, inspection readiness, and operational excellence across the organization.

Responsibilities

• Lead and support investigations of Quality Events like deviations and other quality-related issues
• Facilitate root cause analyses and support the definition, implementation and tracking of CAPAs
• Ensure GMP-compliant documentation and high-quality records within electronic quality systems
• Support the creation, update and review of cross-functional SOPs and other quality-relevant documentation
• Support Change Control activities and the implementation of quality-related process changes
• Assist Operations during audits and inspections and support the execution of resulting action plans
• Identify recurring quality and compliance issues and support sustainable corrective measuresCollaborate with Operations, Quality Assurance, subject matter experts and other support units to continuously strengthen compliance standards and quality performance
• Provide guidance and support to teams on quality system processes and documentation

Qualifications

• Degree in Life Sciences, Chemistry, Pharmacy, or a related scientific discipline
• Proven experience in a GMP-regulated environment, preferably within a CMC testing environment, Quality Control, manufacturing, or lab operations
• Solid understanding of investigations, root cause analysis, and CAPA management
• Familiarity with GMP documentation, quality systems, and change management processes
• Strong analytical and problem-solving skills with a structured and pragmatic approach
• Excellent interpersonal and communication skills, with the ability to work effectively across functions
• Experience with electronic Quality Management Systems is an advantage
• Fluent in English; German is considered a plus

About Us

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards