Site Quality Senior Manager
il y a 2 semaines
For Our Brussels branch and reporting to the QA Director, we are seeking a highly skilled and motivated Site Quality Senior Manager to join our team.
You will have a vital role in ensuring the overall quality and compliance of our organization's operations.
The ideal candidate will be in charge of identifying, evaluating, and managing risks associated with product quality and regulatory compliance.
You will collaborate with diverse teams to devise and execute risk mitigation strategies and lead continuous improvement efforts.
Furthermore, the Quality Risk Manager will oversee effective communication channels with internal stakeholders, regulatory bodies, and external partners.
Responsibilities
Develop and execute quality enhancement strategies: Responsible for creating and implementing strategies to enhance quality standards organization-wide. This involves identifying areas for enhancement, establishing objectives, and devising action plans. Process optimization: Collaborate with cross-functional teams to identify and streamline processes impacting quality. This may include conducting process audits, analyzing data, and implementing process enhancements for improved efficiency and efficacy. Additionally, develop and enforce policies, procedures, and guidelines to ensure compliance. Training and development: Provide support to the training team to boost their grasp of quality principles and practices. This may involve hosting workshops, crafting training materials, and leading knowledge sharing sessions. Monitoring performance and reporting: Monitor critical quality metrics and performance indicators to evaluate the success of quality enhancement initiatives. Regular reporting and transparent communication of outcomes to stakeholders are essential for ensuring accountability and transparency. Change management: As a Quality Transformation Manager, play a pivotal role in executing organizational changes. This includes involving stakeholders, addressing resistance, and fostering a culture of continual improvement. Establish and implement an extensive site Quality Risk Management program aligning with regulatory requirements, industry best practices, and corporate initiatives, Recognize and evaluate potential risks to product quality, regulatory compliance, and patient safety throughout the organization, Conduct risk assessments, including hazard identification, risk estimation, and evaluation of risk mitigation strategies, Work with cross-functional teams to devise and execute risk mitigation plans, Supervise and review risk management activities, including the efficiency of implemented controls and corrective actions, Offer guidance and assistance to teams in identifying and tackling quality-related risks during product development, manufacturing, and distribution processes, Facilitate risk management training and workshops to boost risk awareness and cultivate a culture of quality and compliance, Stay informed about industry trends, regulatory alterations, and emerging risks, and proactively suggest enhancements to the quality risk management program, Sustain effective communication channels with internal stakeholders, regulatory entities, and external partners concerning quality risk management affairs, Take part in internal and external audits and inspections, delivering necessary documentation and support as needed, Report and escalate emerging risks to the site leadership team.Requirements
Minimum 10 to 15 years of experience in various quality-related roles, such as quality assurance, quality systems, quality control, risk management, or a related sector within the pharmaceutical, biotechnology, or medical device industry, Being a qualified pharmacist, Strong communication and interpersonal skills, with the capacity to collaborate and influence stakeholders at all organizational levels, Solid organizational skills, with the ability to prioritize and handle multiple tasks concurrently in a fast-paced setting, Excellent analytical, problem-solving, and decision-making capabilities, Familiarity with pertinent regulations and standards, Profound understanding of quality risk management principles, methodologies, and tools (e.g., FMEA, HACCP, Ishikawa diagrams), Proficiency in conducting risk assessments and devising risk mitigation strategies, Data-focused mindset emphasizing continual improvement and compliance, Desirable professional certifications related to quality management and risk assessment (e.g., Six Sigma, ASQ, RAPS), Experience in people management (direct & indirect) Fluent in English, with preference for French/Dutch proficiency.Benefits
An engaging role with opportunities for growth and skill enhancement in a global company, operating in the most rigorous quality setting within the pharmaceutical industry – a sterile business Potential for personal evolution within an international corporation Clear career progression and annual performance evaluation and feedback mechanism Contributory pension scheme and benefits package available from day one of employment (health/group insurance) Meal Vouchers, Eco Voucher, Company Car 36 days of vacation + public holidaysCatalent's key leadership competencies used for interviewing and Performance & Development:
Delivers Results Leads with Integrity and Respect Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops-
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