RP · GMP · GDP · PHARMA
Expertise.Responsibility.Lasting Results.
I support pharmaceutical companies in Switzerland with regulatory responsibilities, quality leadership and GMP/GDP compliance – providing personal, independent support backed by more than 20 years of experience in the pharmaceutical industry.
RESPONSIBLE PERSON (RP) SINCE 2010 – WITH EXPERIENCE IN APIs, FINISHED MEDICINAL PRODUCTS, WHOLESALE DISTRIBUTION AND INTERNATIONAL QUALITY ORGANISATIONS.
Experience
Experience & expertise
- 20+ Years in the Pharmaceutical Industry
- 16+ Years in Quality & Compliance
- Responsible Person (RP) Since 2010
- Leadership Experience
- APIs & Finished Medicinal Products
- GMP & GDP
- Swissmedic · EU · US FDA · ANVISA
- International Experience
Client Situations
When I can support you
Quality and compliance assignments often arise when regulatory responsibility needs to be ensured at short notice, additional senior expertise is required, or a complex regulatory situation calls for a structured solution.
Ensuring Responsible Person (RP) coverage
A position needs to be filled, covered temporarily or assigned externally within an appropriate regulatory framework.
Bridging quality leadership gaps
A leadership position is vacant, or additional senior management capacity is temporarily required.
Preparing for inspections
An inspection or audit is approaching, and inspection readiness, documentation, processes or organisational structures require a critical review.
Assessing compliance gaps
There are uncertainties regarding GMP/GDP, quality systems or regulatory requirements, and the actual need for corrective action requires a structured assessment.
Positioning
Senior quality expertise – direct, personal and straightforward.
I support companies where regulatory responsibility, technical assessment and pragmatic implementation come together. You work directly with me – from the initial assessment through to implementation.
Core Competencies
What you can rely on
External Responsible Person (RP)
If you require a Responsible Person but do not wish to establish a permanent internal RP structure, I can undertake RP assignments within the agreed scope and applicable legal framework. My experience as a Responsible Person since 2010 covers finished medicinal products, API manufacturing and wholesale distribution, as well as the interfaces between management, Quality Assurance (QA), operations and external partners. Temporary arrangements and deputy coverage are also possible.
Senior quality leadership
I provide support during vacancies in QA leadership positions, organisational changes, site integrations and challenging compliance situations. My experience ranges from leading a QA organisation of approximately 25 employees to global compliance responsibility for seven international API manufacturing sites in Europe, the USA and China. My focus is on clearly defined responsibilities, effective quality systems and practical implementation.
GMP & GDP Compliance
GMP and GDP requirements must not only be met from a regulatory perspective but also be effective in day-to-day operations. I provide support in areas including QMS assessments and compliance gap assessments; deviation, CAPA, change control and complaint management; SOPs and QMS harmonisation; Quality Agreements; supplier and contract manufacturing oversight; GDP and wholesale distribution; and compliance remediation.
Inspection & Audit Readiness
I have supported customer audits and regulatory inspections in an international pharmaceutical environment, including inspections involving Swissmedic, the US FDA, European regulatory authorities, ANVISA and Chinese regulatory authorities. I provide support with inspection readiness, mock inspections, the assessment of critical compliance issues, the preparation of remediation measures, and assistance during audits and regulatory inspections.
Services
Practical support where quality matters
External Responsible Person (RP)
Assuming regulatory responsibilities within the agreed scope and applicable legal framework – providing personal, independent support backed by extensive experience as a Responsible Person.
Deputy Responsible Person (RP)
Ensuring continuity of regulatory responsibility during absences, vacancies or transitional periods.
Interim Quality Leadership
Senior-level support during vacancies, organisational changes or periods requiring temporary leadership within the quality function.
GMP & GDP Compliance / QMS
Structured assessment of compliance-related issues and support in implementing solutions that meet applicable regulatory requirements.
Inspection & Audit Readiness
Structured preparation for audits and regulatory inspections – from assessing the current situation and identifying gaps through to preparing the organisation.
Training
Practical on-site training in GMP/GDP, Responsible Person (RP) responsibilities, deviation management and CAPA – tailored to your company's requirements and operational processes.
Quality Agreements & Supplier Qualification
Support in preparing and negotiating Quality Agreements, qualifying and auditing suppliers, and conducting due diligence assessments.
Specific Quality Projects
Targeted support for specific quality-related issues and time-limited projects – from technical assessment through to pragmatic implementation.
Start-up / Biotech Quality Support
Support in establishing appropriate quality structures and processes for growing pharmaceutical and biotechnology companies.
The scope of our collaboration depends on your specific requirements – from a one-off assessment to longer-term support.
My Approach
Understand. Assess. Implement.
Understand
I begin by understanding the actual problem, rather than starting with a standard solution.
Assess
I then assess the risks, regulatory requirements and organisational circumstances.
Implement
Together with the client, we establish clear priorities and define practical, achievable measures.
About Me
Dr. Enno Schweinberger
My professional background combines operational Quality Assurance, regulatory responsibility and international quality management. These different perspectives shape my approach: thorough in assessment, clear in responsibility and pragmatic in implementation.
From 2027, I will bring this experience to selected assignments for pharmaceutical and life sciences companies as an independent consultant.
Complex challenges deserve clear answers.
Whether you require support with a Responsible Person (RP) assignment, regulatory responsibilities, quality leadership or GMP/GDP compliance, I can help you assess your specific situation and identify the next steps.
Direct Contact with Dr. Enno Schweinberger