Caring for skin means caring for people.
The R&D Site Quality Manager is to provide leadership and GMP quality oversight at the Beiersdorf Innovation Center. The R&D GMP Site Quality lead will ensure all applicable GMP activities are in full compliance with internal standards and external regulations. They play a significant role in the ability of the site to operate, significantly influencing how all Product Development processes meet expectations.
Key Tasks:
- Lead the implementation, maintenance, and continuous improvement of the R&D GMP Quality Management System including the creation/revision/review of Quality System Documents (QSDs), local administration of change management, timely completion of deviations and investigations, implementation of corrective and preventive measures.
- Be responsible for document control/archiving processes while maintaining an awareness of current GMP trends and regulatory authority expectations.
- Direct the activities to ensure facilities, equipment and processes are qualified, calibrated and operated consistent with CGMPs.
- Provide quality oversight of all metrology and qualification related activities including, but not limited to, validation plans and protocols and IQ/OQ/PQ documents (facility, equipment and software related).
- Oversee the review and disposition of raw materials, stability/product batches and consumer study and clinical trial materials etc. in compliance with internal standards and GMP regulations.
- Review data and documentation for GMP activities such as registration stability, analytical protocols and reports (validation, transfer), specifications, batch documentation, Certificates of Analyses, etc.
- Represent GMP Quality on R&D project teams. Provide input into development strategies to support innovation, achieve business objectives and maintain GMP compliance. Raises and offer solutions for quality issues to the VP of US R&D in a timely manner.
- Work with the other development sites to maintain site metrics, preparing trend analysis, recommending corrective actions and learning across sites.
- Represent R&D site QA in internal audits and regulatory inspections. Ensures responses to audit observations/inspection findings (internal and external) are completed in a satisfactory and timely manner.
- Conduct/Coordinate R&D Annual GMP Training.
- Lead the implementation of Corporate and Regional Beiersdorf Policies, Guidelines and SOPs in R&D.
- Lead the efforts to monitor and track QSD (SOP’s, etc.) within functions.
- Review Clinical protocols and study related monitoring procedures (not site visits).
- Support Validation activities at the site to ensure systems meet standards.
- Exhibit professionalism and foster teamwork to create an environment of support that leads to productivity of R&D personnel and ensures GMP compliance.
- This position has potential to have a direct report focused on project management specific to QA.
Qualifications:
- Minimum Bachelor’s Degree in Quality Assurance, Chemistry or related science.
- Minimum 7-10 year’s experience in a GxP regulated industry.
- Minimum 7-10 years of experience in R&D Quality Assurance.
- Thorough knowledge of GMPs and product development processes.
- Ability to work cooperatively in teams and peer relationships.
- Ability to effectively manage multiple, complex and changing priorities.
- Work on-site 4 days a week.
- Excellent communication skills and good influencing skills.
At Beiersdorf, we embrace Diversity and aim to provide equal opportunities to all of our applicants – regardless of e.g. gender, sexual identity, nationality, ethnicity, religion or ideology, disability or age. We would therefore kindly ask you to include only information and data in your documents which are relevant for the assessment of your application (e.g. curriculum vitae with relevant references and certificates).
Beiersdorf is an Equal Opportunity Employer.
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