Director GMP Compliance Remediation & Support - Germany
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- This position is critical in our Manufacturing Divisional effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.
- Act as a cross-functional leader to Simplify, Standardize & Sustain our Compliance Remediation and Support department.
- This Director will ensure cross functional alignment and act as change agent for Director, Multi Products Compliance and Remediation Support.
- Lead development and execution of significant innovation projects driving operational improvements related to all the topics supporting multi products– Compliance, Remediation and Support.
- Support CAPA and inspection readiness processes that are critical to ensure a standardized and sustained QMS.
- Support alignment for those chapters related to quality/compliance and data integrity including alignments from Global QMS that may apply to inspection readiness, inspection support and remediation.
- Ensure robust processes are in place and in use to maintain CAPA management and remediation support.
- This includes authoring documents, data entry of metrics and CAPA supporting compliance, remediation, and support.
Lead during efforts to support inspection remediation and CAPA management processes, demonstrated experience as a lead during Board of Health related inspections.
- Develop the strategy and lead the implementation of the CAPA management and remediation across the Manufacturing Division network, GMP and AH activities including Research Labs; define the strategy for global requirements to drive harmonization of processes and systems
- Lead the implementation of QMS requirements related to CAPA Management and Compliance Remediation Support.
- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignments related to GMP and DI requirements.
- Provide leadership and technical direction on regulatory GMP/GDP requirements
- Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the Manufacturing Division network
- Develop and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance across the Manufacturing Division network
- Influence and advocate our Manufacturing Division position on CRS processes related to HA expectations through a strong network of external connections and effective external engagement
- Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements
- Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain our Manufacturing Division CRS and associated document
- Lead development and execution of significant innovation projects driving operational improvements; this will require cross-functional support within the Global CRS team and Global QA and External Affairs.
Education Minimum Requirement:
Bachelor's degree in Life Sciences, Engineering or related relevant discipline. Advanced degree preferred.
Required Experience and Skills:
- Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management
- Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred
- Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS in a drug, device and biologics manufacturing environment
- Strong project management skills
- Capable of working and communicating effectively with all levels of the organization globally
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
- Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance
- Proven ability to effectively initiate and drive change across the Manufacturing Division network
- Self-motivated with a high degree of ownership and accountability for results
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