Cold Chain & Logistics Quality Business Owner
Location: Barcelona
Job description: You will be in charge to develop and implement Warehousing, Distribution & Transportation plans, processes and policies and support activities of storage and movement of materials and finished goods.
Key Responsibilities:
Cold Chain Management:
Develop and implement global cold chain management strategies, policies, and procedures to ensure the integrity and quality of temperature-sensitive products throughout the supply chain.
Collaborate with cross-functional teams, including procurement, manufacturing, quality assurance, regulatory affairs, and distribution, to ensure effective coordination and communication.
Evaluate and select cold chain logistics partners, including carriers, freight forwarders, packaging suppliers, and cold storage facilities, to ensure compliance with global regulations and industry best practices.
Supervise and manage the performance of cold chain logistics partners, including conducting regular audits, inspections, and performance reviews.
Develop and maintain positive relationships with regulatory authorities, industry associations, and other stakeholders to stay updated on global cold chain regulations, standards, and emerging trends.
Implement robust temperature monitoring systems and quality control processes to proactively identify and mitigate risks to product integrity.
Lead investigations and root cause analysis for cold chain deviations, implementing corrective and preventive actions to prevent reoccurrence.
Develop and deliver cold chain training programs to internal and external stakeholders to ensure awareness and adherence to cold chain management standards.
Stay up to date with advancements in cold chain technologies, packaging solutions, and transportation modes, and recommend innovative solutions to enhance operational efficiency and cost-effectiveness.
Provide leadership and mentorship to the global cold chain management team, encouraging a culture of continuous improvement, collaboration, and excellence.
Quality Compliance:
Be the quality partner of cold chain and distribution related teams review/approval of change controls, review and/or approval of guidance/procedures/WoW and review and approval of deviations including definition and implementation of CAPA where needed.
Act as subject matter expert (SME) for documenting "shipping qualification" protocols and reports within logistics.
Provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
Maintain the technical shipping qualification matrix and the framework of distribution processes.
Drive cost improvement of shipping systems and implement new shipping systems solutions in relation with the business needs.
Ensure audit readiness including GDP inspection (MHRA, FDA, country specific ANVISA…) and internal and external audit (Customers, Corporate…) readiness at all times and act as SME during these inspections and audits.
Establish, define and maintain shipping qualification and shipping risk analysis processes that meet current standards and guidance.
Set up and maintain standard templates of shipping qualification test protocols and test reports in accordance with the relevant regulation.
Drive and lead the relevant regulatory requirements into a global strategy for Cold Chain management.
Skills & Qualifications:
Background in Medical Device, pharmaceutical or biopharmaceutical industry.
A demonstrated knowledge and execution of Quality System Management.
Knowledge of electronic training management systems.
Knowledge of different regulations: medical device applicable regulation, GMP & GDP regulatory requirements.
What we offer in return:
Work for an organization that embraces diversity & inclusion.
Receive a competitive compensation package with bonus structure and extended benefit package.
Work in a hybrid work culture.
Participate in feedback Loops, establishing a personalized career path.
Join a growing company that believes in ownership from day one.
Process steps:
Send your CV in English.
If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
The next step is a virtual conversation with the hiring manager.
The final step is a panel conversation with the extended team.
Our people make a difference: At Galderma, you'll work with diverse individuals and we value what every member of our team brings.
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