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BakerHicks

Designs and delivers engineering projects

Quality Assurance Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeVisp, SwitzerlandNo salary listed

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, biotechnology, or medical-device industry environment are required.
  • Extensive knowledge of quality assurance, qualification, validation, and quality management systems is required.
  • In-depth understanding of EU-GMP, Swissmedic, FDA, and PIC/S requirements is required.
  • The candidate must be able to assess complex quality and compliance matters using analytical and risk-based judgment.
  • Substantial experience handling deviations, changes, CAPAs, and risk analyses is required.
  • Strong communication and consulting skills for working with customers, authorities, and interdisciplinary project teams are required.
  • Experience creating, reviewing, and approving GMP-relevant documentation is required.
  • A structured, precise, and solution-oriented approach to work 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.
  • Take responsibility for 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 such as SOPs, reports, risk analyses, and quality agreements.
  • Conduct compliance assessments, gap analyses, and internal audits.
  • Maintain the qualified status of facilities, equipment, and systems through periodic reviews.
  • Contribute to preparing 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 competent point of contact for customers, auditors, and authorities.
  • Support continuous improvement of quality processes and best practices.
  • Ensure GMP conformity and regulatory compliance within the customer organizations supported.
  • Provide technical leadership and support for qualification, validation, and quality activities.
  • Ensure high quality in GMP documentation and quality-related decisions.
  • Support successful authority inspections and customer and supplier audits.
  • Promote a sustainable quality culture and continuous improvement among customers and within BakerHicks.
  • Further develop BakerHicks' portfolio in quality assurance, compliance, qualification, and validation.

Desired Qualifications

  • Experience in quality assurance for production, laboratory, and infrastructure facilities is desired.
  • Ability to provide technical leadership for qualification and validation projects is desired.
  • Knowledge of computer system validation, data integrity, or cleaning validation is desired.
  • Proficiency with quality management systems and electronic quality systems such as SAP, MasterControl, TrackWise, or Veeva is desired.
  • Experience with authority inspections and customer audits is desired.
  • Knowledge of multidisciplinary life-science projects in a consulting or project environment is desired.

About the Company

BakerHicks

Designs and delivers engineering projects

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
Not listed
Total funding
Not listed
Headquarters
Warwick, United Kingdom
Founded
1957

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