Site Quality Senior Manager

Catalent

Brussels, Belgium

For Our Brussels site and under the authority of the QA Director, we are looking for a highly skilled and motivated Site Quality Senior Manager to reinforce our team.

You will play a crucial role in ensuring the overall quality and compliance of our organization's operations.

The successful candidate will be responsible for identifying, assessing, and managing risks related to product quality and regulatory compliance.

You will collaborate with cross-functional teams to develop and implement risk mitigation strategies and drive continuous improvement initiatives.

The Quality Risk Manager will also be responsible for maintaining effective communication channels with internal stakeholders, regulatory agencies, and external partners.

The Role

Quality Transformation

Develop and implement quality transformation strategies: You will be responsible for designing and implementing strategies to improve quality standards across the organization. This includes identifying areas for improvement, setting goals, and developing action plans;
Process optimization: You will work closely with cross-functional teams to identify and streamline processes that impact quality. This may involve conducting process audits, analyzing data, and implementing process improvements to enhance efficiency and effectiveness. This includes developing and implementing policies, procedures, and guidelines to ensure compliance;
Training and development: You will provide support to the training team to enhance their understanding of quality principles and practices. This may involve conducting workshops, creating training materials, and facilitating knowledge sharing sessions;
Performance monitoring and reporting: You will monitor key quality metrics and performance indicators to assess the effectiveness of quality improvement initiatives. Regular reporting and communication of results to stakeholders will be essential to drive accountability and transparency;
Change management: As a Quality Transformation Manager, you will play a critical role in managing change within the organization. This involves engaging stakeholders, addressing resistance, and driving a culture of continuous improvement.

Risk Management

Develop and implement a comprehensive site Quality Risk Management program in alignment with regulatory requirements, industry best practices and corporate initiatives;
Identify and assess potential risks to product quality, regulatory compliance, and patient safety across the organization;
Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies;
Collaborate with cross-functional teams to develop and implement risk mitigation plans;
Monitor and review risk management activities, including the effectiveness of implemented controls and corrective actions;
Provide guidance and support to teams in identifying and addressing quality-related risks during product development, manufacturing, and distribution processes;
Facilitate risk management training and workshops to enhance risk awareness and foster a culture of quality and compliance;
Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the quality risk management program;
Establish and maintain effective communication channels with internal stakeholders, regulatory agencies, and external partners regarding quality risk management matters;
Participate in internal and external audits and inspections, providing necessary documentation and support as required;
Report and escalate to the site leadership team the emerging risks.

The Candidate

Minimum of 10 to 15 years of experience in various quality related area, such as quality assurance, quality systems, quality control, risk management, or a related field within the pharmaceutical, biotechnology, or medical device industry;
Being a pharmacist eligible as a qualified person;
Effective communication and interpersonal skills, with the ability to collaborate and influence stakeholders at all levels of the organization;
Strong organizational abilities, with the ability to prioritize and manage multiple tasks simultaneously and evolve in a fast-changing environment;
Excellent analytical, problem-solving, and decision-making skills;
Familiarity with relevant regulations and standards;
Strong knowledge of quality risk management principles, methodologies, and tools (e.g., FMEA, HACCP, Ishikawa diagrams);
Experience in conducting risk assessments and developing risk mitigation strategies;
Data-oriented mindset with a focus on continuous improvement and compliance;
Professional certifications related to quality management and risk assessment (e.g., Six Sigma, ASQ, RAPS) are desirable;
Fluent in English, French/Dutch preferred.

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