Head of Quality
Alcami Corporation
Weert, Netherlands
8 dagen geleden

Position Summary :

As a member of the local Site Leadership Team the focus of this position are to ensure :

  • regulatory compliance to all applicable quality standards and respective market requirements (pharma, medical device, );
  • adequate quality management & quality assurance systems primarily based on ISO 9001 and cGMP requirements;
  • state-of-the-art analytical services for quality control in a cost-efficient and timely manner;
  • Coaching, engaging and development of employees within the quality department.
  • The Quality department consists of the two sub-departments Quality Control (QC) and Quality Assurance (QA).

    Operationally, the department supports the application of the appropriate quality standards, in which the department has an advising, supporting and verifying role in respect to line management.

    Position in organization

    The Head of Quality is directly reporting to the Vice President Quality and Regulatory Compliance.

    Functionally the Head of Quality is reporting to the Site Director.

    Key Job Responsibilities :

  • Responsible for the quality management system on site :
  • Ensuring compliance of this system with applicable laws and regulations and actual and future customer demands, including a periodic review of this;
  • Supervising the efficacy of and compliance with this system internally;
  • Preventing the delivery of deficient products to customers without their prior consent;
  • Dealing efficiently with incidents, deviations and customer complaints;
  • Dealing with non-compliances;
  • Responsible for the preparation and execution of authority inspections and customer audits, including responses to audit reports and follow up of actions.
  • Responsible for the control of changes in processes to stay in compliance with laws and regulations, customer demands and product registrations.
  • This also includes responsibility to stay / be in compliance with Alcami requirements (e.g. corporate procedures).

  • Responsible for product release, including :
  • Analytical testing and release of product;
  • Continuation / putting on hold production processes in case of quality issues;
  • Execution and approval of deviation / failure investigations.
  • Responsible for the definition and propagation of the quality policy, including :
  • Continuous improvement activities;
  • The anchoring of work processes in procedures and SOPs with respect to all relevant Compliance aspects;
  • The verification and fine-tuning of policies in leadership team meetings.
  • Responsible for training / instruction / education on compliance issues.
  • Expression :

  • Is capable to write in correct English language suitable for the audience.
  • Good control of the Dutch and English both in language and in writing.
  • Education and Experience :

  • At least bachelor’s degree;
  • Minimum of 10 years’ experience in an international production environment or R&D environment;
  • Minimum of 5 years’ management experience
  • Knowledge in the area of cGMP; expert in quality relevant regulations (e.g. EU Eudralex Volume 4 regulations, 21 CFR parts 210 & 211, GAMP, 21 CFR part 11);
  • Extensive experience with quality processes and systems in a cGMP environment
  • Extensive experience with management systems, preferably in the area of quality (ISO 9001 / cGMP)
  • Experience in generating long term plans, policy plans and departmental budgets
  • Knowledge of and insight in company- and work processes and installations;
  • Knowledge of laboratory management and laboratory organizations;
  • An ability to analyze qualitative and quantitative information to draw conclusions and make recommendations, based on clear (scientific) rationale;
  • Excellent problem solving aptitude, communication and multi-tasking skills.
  • Ability to coach, mentor, develop and train employees.
  • Expression :

  • Is capable to write in correct English language suitable for the audience.
  • Fluent in Dutch and English both in verbal and in writing.
  • Alcami Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.
  • Follows all safety policies and leads by example a safety first culture.
  • Produces high quality work product with a focus on first time right.
  • Complies with the company code of conduct and policies and regulatory standards.
  • What We Offer You :

  • Competitive salary with career advancement opportunities
  • Profit sharing bonus plan
  • Holiday allowance of 8% in May and a 13th month payment in November
  • Collective insurance and pension agreement
  • An ambitious work environment with a dedicated and enthusiastic team
  • Contact and information :

    Application including a motivation letter can be addressed to Marilyn Raat, Head of HR

    or our website.

    Acquisition based on the occasion of this advertisement will not be appreciated

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