Senior Specialist Compliance Excellence (m/f/d)

Job Description

Our Company`s 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 Senior Specialist Compliance Excellence serves as an experienced operational compliance and quality systems professional for GMP biologics manufacturing at Schachen. 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 Tech Transfer. The position focuses on execution, problem solving, and project leadership, while contributing to broader compliance excellence initiatives.

End-to-End Compliance & Issue Resolution:

• Lead and drive resolution of complex GMP quality notifications (QNs), 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, escalating when required.

• Support and contribute to robust root cause analysis and sustainable CAPA definition.

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 and change strategies.

Operational Support & Decision Enablement:

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

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

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

Performance Management & Compliance Excellence:

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

• Drive continuous improvement through data analysis, trend evaluation, and operational excellence tools such as Gemba and 5S.

• Identify and implement improvements within area of responsibility.

Inspection Readiness & Quality Systems:

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

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

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

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 execution of projects and operational readiness.

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.

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

• Coach and guide junior team members and support knowledge sharing.

Required Qualifications:

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

• Solid experience in GMP-regulated biologics manufacturing with strong knowledge of compliance and quality systems.

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

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

• Strong communication skills in German and English with the ability to influence within project teams.

Required Skills:

Adaptability, Change Control Processes, Customer-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Support, Technical Transfer

Preferred Skills:

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Search Firm Representatives Please Read Carefully
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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.