Head of Quality

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.

The Company

This is one of the biggest pharmaceutical companies that develops, produces and sells medicines.

Role Description

- Manage Quality
Lead the site's Quality Systems team in establishing and maintaining quality at the department in accordance with Site SOP’s, regulatory guidelines and cGXP compliance requirements.
Maintain high standards of quality at the department through managing and continuously improving the effectiveness of the department quality processes and systems.

- Measure and Monitor Execution
Consistently measure, monitor and report site quality key performance indicators

- Manage Team and Resources
Identify, develop, and retain qualified people to implement the quality processes. Run an efficient and effective Quality Systems organization through managing the department site budget and resources.
Build a team that has the technical expertise, personal skills and interpersonal skills needed to influence site Operations and is conversant in application of regulations

Responsibilities

Manage employees of the Quality System Department:
- Maintain a team that has the technical expertise, personal skills and interpersonal skills needed to perform their duties in line with the Site expectations.
- Ensure an effective internal communications structure with relevant departments
- Supervise the performance of the work (both in terms of volume and quality) as well as the lead time
- Manage Department Processes: Including and not limited to timely management of investigations, CAPAs, coordination of Regulatory commitment, GRAs,
- Manage team through talent identification, active performance management, succession planning, employee development, mentoring and modeling
behavior according to our values.

Manage the activities of the Quality Systems Department:
- Ensure that proposed changes to suppliers, processes, equipment, systems, procedures, and basic documents are assessed according to current
CGXP guidelines en Global requirements.
- Ensure that validation of systems, equipment and processes are timely performed and reported, inform management of any discrepancy.
- Manage the documents in a robust EDMS and ensure proper archiving for non EDMS documents
- Ensure product transfers across sites also include the transfer of quality information (knowledge, documentation, processes, etc.).
- Execute aspects with regard to the Occupational Health and Safety Act
- Plan, manage and prioritize the department budget and make proposal for the allocation of workloads and resources (systems, equipment, FTE's) to meet
compliance and business requirements.
- Manage and maintain the LIMS locally and support Global initiatives, e.g. upgrades, validations, procedures.
- Ensure robust quality systems that include monitoring and control of the manufacturing process and facilities

Requirements

- University level (Pharmacy / Chemistry) or HBO+ with several years of experience in a manager position in the pharmaceutical industry.
- Experience with pharmaceutical processes, techniques, and cGXP
- Familiar with process automation
- Ability to collaborate with internal team to manage a successful inspection and provide timely and thorough responses to the regulatory authority
- Ability to stay current with and apply in daily activities a strong working knowledge of cGXPs/ regulatory guidances to ensure full compliance
- Understands the meaning and impact of quality metrics and agility in appropriate and timely course correction and resolution
- Knowledge of Product types or profile codes / classes e.g.: Non Sterile (Solid, liquid, cream, lotion, suspension); Parenteral; API; Medical Devices; Large
Molecule
- Ability to promote continuous process improvement/ efficiency

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.