Quality Assurance Manager & GMP transition lead
PhytoVitality AG
The Company
PhytoVitality is a leading Swiss producer of medicinal cannabis for both domestic and international pharmaceutical markets. Our state-of-the-art cultivation and processing facility near Zurich operates according to the highest quality standards and is currently transitioning from a GACP-certified operation towards full EU-GMP manufacturing compliance.
The company has already initiated the planning and design phase of its GMP processing facility and quality systems, creating a unique opportunity to play a leading role in shaping and implementing the future GMP operation from the ground up.
The Role
To support this transition, we are looking for an experienced and hands-on Quality Management- and GMP expert who will take a leading role in driving the organization's GMP transformation.
This position combines:
- Quality Management
- GMP implementation
- Project leadership
- Regulatory coordination
- Operational quality oversight
- Organizational change management
You will play a key role in upgrading and further developing our Quality Management System from a GACP- and GDP environment towards a fully GMP-compliant pharmaceutical processing operation. The role requires both strategic oversight and hands-on execution. You will work closely together with the existing Quality Management Department, general management and external consultants where needed.
As part of this next strategic phase, we are looking for an experienced and hands-on Quality professional who can lead and coordinate our GMP transformation across the organization.
Main responsibilities:
GMP Transition & Quality Leadership
- Lead and coordinate the company-wide transition from GACP & GDP towards EU-GMP manufacturing compliance;
- Upgrade, expand and implement the Quality Management System (QMS) to GMP standards;
- Establish and strengthen a GMP quality culture and mindset throughout the organization;
- Define and implement quality strategies, procedures and quality governance structures.
GMP Compliance & Operations
Oversee all GMP-related quality activities and systems, including:
- Deviations, CAPAs and Change controls
- Risk assessments and investigations
- Document control;
- Supplier and Customer qualifications Batch documentation – incl. batch releases
- Quality oversight of production and processing activities
Validation & Qualification
Coordinate and oversee:
- Validation master planning
- Process- and Cleaning validation
- Equipment qualification (IQ/OQ/PQ)
- CSV activities where applicable
- Commissioning and qualification activities
Regulatory & Inspection Readiness
- Serve as primary quality contact for authorities and inspections
- Support GMP licensing activities and authority communication (e.g. Swissmedic)
- Prepare and lead internal/external audits and GMP inspections
- Ensure compliance with applicable Swiss and EU pharmaceutical regulations
FvP / Responsible Person
- Fulfill the responsibilities of the Fachtechnisch verantwortliche Person (FvP), if qualified under Swiss regulations.
Project Management & Coordination
- Coordinate cross-functional GMP implementation projects
- Manage timelines, priorities and external consultants
- Support the organization in making practical and compliant quality decisions
Qualifications we are looking for a candidate with:
- Solid understanding of EU-GMP requirements and pharmaceutical quality systems
- Experience within Medicinal Cannabis, Phyto-pharma, biotech or is highly preferred
- Proven experience implementing, upgrading or managing GMP Quality Management Systems
- Experience with GMP transition projects, facility upgrades or scale-up environments
- Eligibility to act as FvP / Responsible Person under Swiss legislation is a strong advantage
- A pragmatic, hands-on and solution-oriented mindset
- Ability to operate both strategically and operationally
Skills & Personal Profile
- Strong project management and coordination skills
- Excellent communication skills in English and German (bilingual QM system)
- Ability to guide teams through organizational change
- Strong analytical and problem-solving abilities
- Comfortable operating in a fast-growing and evolving environment
What We Offer
- A unique opportunity to lead a full GMP transformation project within a rapidly growing medicinal cannabis company
- Significant impact on the future direction of the organization
- A highly dynamic and entrepreneurial environment
- Collaboration with experienced management and external GMP experts
- Long-term growth opportunities within an international pharmaceutical market
