Cold Chain
hace 3 semanas
Cold Chain & Logistics Quality Business Owner Location: Barcelona Posted: 6 Days Ago End Date: December 13, 2024 (22 days left to apply) 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.
You will act as subject matter expert (SME) for documenting "shipping qualification" protocols and reports within logistics.
You will provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
You will be responsible for maintaining the technical shipping qualification matrix and the framework of distribution processes.
You will drive cost improvement of shipping systems and implement new shipping systems solutions in relation with the business needs.
You will 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.
You will establish, define and maintain shipping qualification and shipping risk analysis processes that meet current standards and guidance (Good Distribution practice, Good documentation practice, ISPE cold chain management, process qualification standard and guidance, regulatory requirement).
You will set up and maintain standard templates of shipping qualification test protocols and test reports in accordance with the relevant regulation (URS, OQ, PQ).
You will drive and lead the relevant regulatory requirements (GDP, USP, ASTM, ISO, ….)
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: You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
You will receive a competitive compensation package with bonus structure and extended benefit package.
You will be able to work in a hybrid work culture.
You will participate in feedback Loops, during which a personalized career path will be established.
You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
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 people who are like you.
And people that are different.
We value what every member of our team brings.
Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
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