Quality Assurance Manager
No salary listed
Mid
Bachelor's
Switzerland
In PersonProject location is Basel, Switzerland.
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A university degree in pharmacy, chemistry, biotechnology, life sciences, engineering, or a comparable field is required.
- Substantial expertise and several years of practical experience in a GMP-regulated pharmaceutical, biotechnological, or medical technology environment are required.
- Extensive knowledge of Quality Assurance, qualification, validation, and quality management systems is required.
- A thorough understanding of EU-GMP, Swissmedic, FDA, and PIC/S requirements is required.
- Analytical thinking and the ability to assess complex quality and compliance topics using a risk-based approach are required.
- Experience handling deviations, changes, CAPAs, and risk analyses is required.
- Communication and consulting skills for working with customers, authorities, and interdisciplinary project teams are required.
- Experience preparing, reviewing, and approving GMP-relevant documentation is required.
- A structured, precise, and solution-oriented work approach is required.
- Very good spoken and written German and English are required.
Responsibilities
- Advise and support customers in implementing and maintaining GMP-compliant quality management systems.
- Oversee Quality Assurance throughout the life cycle of production, analytical, and infrastructure facilities.
- Review, assess, and approve qualifications, requalifications, maintenance activities, technical changes, deviations, and CAPAs.
- Provide technical leadership for qualification and validation activities within investment and operational projects.
- Review and release qualification and validation documentation, including URS, RA, DQ, IQ, OQ, PQ, and VMP.
- Create, review, and approve GMP-relevant documents, including SOPs, reports, risk analyses, and quality agreements.
- Conduct compliance assessments, gap analyses, and internal audits.
- Ensure the qualified status of facilities, equipment, and systems through periodic reviews.
- Contribute to proposals, effort estimates, and consulting services in Quality and Compliance.
- Ensure compliance with regulatory requirements and the quality standards of customers and BakerHicks.
- Promote a sustainable quality and compliance culture within customer projects.
- Provide technical support and coaching to project teams on GMP, quality, and compliance matters.
- Ensure risk-based and pragmatic decision-making on quality-related matters.
- Represent BakerHicks as a knowledgeable point of contact for customers, auditors, and authorities.
- Support continuous improvement of quality processes and best practices.
- Ensure GMP conformity and regulatory compliance within supported customer organizations.
- Provide technical leadership and support for qualification, validation, and quality activities.
- Ensure high-quality GMP documentation and quality-related decisions.
- Support successful authority inspections and customer and supplier audits.
- Promote a sustainable quality culture and continuous improvement for customers and within BakerHicks.
- Develop BakerHicks' portfolio in Quality Assurance, Compliance, Qualification, and Validation.
Desired Qualifications
- Experience with Quality Assurance for production, laboratory, and infrastructure facilities is desirable.
- Ability to provide technical leadership for qualification and validation projects is desirable.
- Knowledge of Computer System Validation (CSV), data integrity, or cleaning validation is desirable.
- Proficiency with quality management systems and electronic quality systems such as SAP, MasterControl, TrackWise, or Veeva is desirable.
- Experience with authority inspections and customer audits is desirable.
- Knowledge of multidisciplinary life-science projects in a consulting or project environment is desirable.
About the company
BakerHicks provides design, engineering and project delivery services for buildings, industrial facilities and infrastructure across the United Kingdom and Europe. Its multidisciplinary teams combine architecture, civil and structural engineering, building services and process expertise for clients in regulated and technically complex settings. Work spans aviation, rail, power, nuclear, life sciences, manufacturing and public facilities, with services adapted to each project and sector. The company supports projects from planning and design through construction, commissioning, handover and operational management. Founded in 1957, it is headquartered in Warwick, Warwickshire.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Warwick, United Kingdom
Founded
1957
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Simplify's Take
What believers are saying
- Working patterns include flexibility: BakerHicks explicitly offers flexible and hybrid working.
- Leadership development has a formal programme: BakerHicks describes peer training through employee accounts on its experienced-hire page.
- Graduates receive chartership guidance: the Motherwell civil and structural scheme offers tailored mentorship and assessment preparation.
What critics are saying
- Graduate eligibility is restricted: the Motherwell scheme excludes Graduate visa holders and candidates needing future Skilled Worker sponsorship.
- Security clearance affects eligibility: the senior mechanical building-services role requires obtaining and maintaining appropriate clearance.
- Design duties extend onto sites: the senior mechanical building-services role includes site surveys and construction-stage work.
What makes BakerHicks unique
- Design reviews become immersive: BakerHicks uses augmented and virtual reality to explore buildings before construction.
- Asset data survives handover: BakerHicks has a dedicated Asset Information Service covering verification, tagging and registration.
- Carbon analysis starts early: BakerHicks uses CarboniCa to identify design carbon hotspots.
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