Carry out quality oversight of external (TPM) manufacturing sites. Propose and ensure implementation of quality strategy that minimizes the risk of regulatory actions against Ferring. Promote and take ownership for influencing strategy decisions so that they meet the good practice standards established by the policies of the Organization, Health Authorities and current law. Deputy of Senior Director Manufacturing Quality Business partner of the allocated VP Manufacturing division;
Lead and manage all quality and compliance related aspects associated to External Manufacturing at Ferring in a complex environment (25-30 TPMs, regular addition of TPMs through BD, strong dependency on key TPMs, potential dual sourcing with Ferring sites, …);
Drive corporate quality oversight and promote quality improvements by preventing and mitigating quality risks which can jeopardize Ferring ‘interests (License to operate, Supply continuity, reputation);
Propose new ways of working to increase efficiency and effectiveness of Quality Oversight of TPMs;
Reinforce links with Ferring manufacturing sites in case of dual sourcing (internal/external) and ensure continuous alignment of practices.
RESPONSIBILITIES AND DUTIES:
Quality and Compliance
Lead quality oversight and carry out quality initiatives at third-parties manufacturing sites (TPM);
Ensure site inspection readiness prior to inspections by health authorities;
Provide strategic operational support to the Global Tech Ops organization;
Manage trouble shooting for critical deviations and follow up on corrective actions;
Participate in the decision-making process of recalls;
Organize, drive and monitor execution of strategic quality initiatives;
Lead the setting of quality agreements between Ferring and TPMs.
Lead the implementation of strategic quality objectives at TPM Sites;
Ensure prioritization of quality audits program based on risk prioritization approach.
Ensure that GMP requirements and CSOPs are implemented and respected at all TPM sites;
Drive establishment, implementation and improvement of Quality standards and quality processes for Global Tech Ops operations related to external manufacturing.
Lead the implementation of the Quality KPI system and lead monitoring of improvement initiative at associated TPM sites;
Assess the quality risk in the area of responsibility and implement risk mitigation actions.
Manage External Quality units in FICSA, FGmbH and FLAS;
Lead and motivate the QA External teams in the achievement of their objectives.
Work with GPRD and Global Tech Ops to provide a GQA input into technical transfer of projects;
Provide support and technical expertise to Global Tech Ops projects.
Drive the QRB process for associated TPM sites;
Provide support and technical expertise to Development and Global Tech Ops initiatives.
REQUIRED EXPERIENCE & COMPETENCES:
Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology);
Strong Knowledge of Business Regulations (EU, FDA and others);
At least 10 years work experience in quality assurance and/or quality control in the pharmaceutical industry with both local and International working experience;
Fluent in English (written and verbal communication);
Excellent interpersonal and communication skills;
Strong business mindset with demonstrated ability of conceptual and strategic thinking;
Good project management skills;
Experiences people management and manager of people manager.