Sr. Specialist Compliance Excellence (m/f/d)

Job Description

Purpose of the Role:

The Schachen site serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement.

The Compliance Excellence Lead (P3) serves as an experienced operational compliance and quality systems professional for GMP biologics manufacturing at the Schachen site. This role is responsible for driving right-first-time execution, enabling operational continuity, and supporting sustained inspection readiness within assigned areas, while balancing regulatory expectations with manufacturing needs.

Operating with a high degree of autonomy within defined scope, the role leads resolution of complex compliance topics, contributes to quality and compliance improvements, and acts as a trusted partner to Manufacturing, Quality, Engineering, and MSAT. The position focuses on independent execution, problem solving, project leadership, and coaching of others while contributing to broader compliance excellence initiatives.

Key Responsibilities:

End-to-End Compliance & Issue Resolution

• Lead and drive resolution of complex GMP deviation records, investigations, impact assessments, and CAPAs within area of responsibility, ensuring timely and high-quality closure.

• Apply risk-based thinking and sound GMP judgment to analyze and resolve non-standard issues.

• Lead or significantly contribute to robust root cause analysis and sustainable CAPA definition.

• Escalate complex or high-risk topics with clear recommendations.

Change & Risk Management

• Manage and support GMP product-related change controls and risk records, ensuring compliant and efficient execution.

• Apply quality risk management principles to manufacturing, technical, and facility topics.

• Provide input into risk assessments, change strategies, and implementation plans.

• Ensure documentation tasks and compliance deliverables are actively controlled through completion.

Operational Support & Decision Enablement

• Provide first-line compliance support for production troubleshooting, investigations, and cross-functional alignment.

• Support Manufacturing teams in resolving operational issues while maintaining GMP compliance.

• Interpret partner and customer needs and translate them into practical, compliant solutions.

• Enable timely decision-making by preparing options, recommendations, and risk-based assessments.

Performance Management & Compliance Excellence

• Support monitoring and tracking of KPIs related to quality, compliance, and operational performance.

• Use data and trend analysis to identify risks, recurring issues, and improvement opportunities.

• Drive continuous improvement through operational excellence tools such as Gemba, 5S, and structured problem solving.

• Identify and implement improvements within area of responsibility.

Inspection Readiness & Quality Systems

• Support ongoing inspection readiness, including compliance of GMP documentation, deviations, investigations, and changes.

• Participate in preparation for internal audits, external audits, and regulatory inspections.

• Represent the functional area during audits or inspections as subject matter expert when required.

• Help strengthen inspection-ready behaviors and compliant execution within assigned areas.

Facility / Engineering Interface

• Perform GMP impact assessments related to facility, equipment, and engineering changes within assigned scope.

• Collaborate with Engineering and Facility Management to ensure compliant project execution and operational readiness.

• Provide compliance input to technical and facility-related topics impacting manufacturing operations.

Project Leadership & Collaboration

• Lead small to mid-scale compliance or quality improvement projects with minimal to moderate complexity.

• Act as project lead or workstream lead, coordinating cross-functional contributors and tracking milestones.

• Build strong working relationships across Manufacturing, Quality, Engineering, and MSAT.

• Coach and guide junior team members and support knowledge sharing across the group.

Required Qualifications:

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.

• Solid experience in GMP-regulated biologics manufacturing, quality systems, compliance, technical operations, or a related area.

• Proven ability to solve complex problems and lead investigations with minimal guidance.

• Strong knowledge of GMP expectations, quality systems, documentation standards, and risk-based decision-making.

• Experience working cross-functionally with Manufacturing, Quality, Engineering, and MSAT.

• Ability to lead projects or workstreams and influence stakeholders within assigned scope.

• Strong communication skills in German and English.

Required Skills:

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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