Sr. Supervisor Quality Systems

DescriptionThis position may represent Quality on APR/PQR (Annual Product Review/Product Quality Review) by being responsible for on time completion of APR/PQR activities, guiding, setting, and standardization of quality/compliance requirements, development of SOPs and providing practical solutions in collaboration with the APR/PQR process owner, local and global team as well as contractor. This individual will comply with applicable regulations and meet the needs of the business and supply chain.Responsibilities:Subject Matter Expert (SME) for APR/PQR quality systems processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.Work in close collaboration with APR/PQR process owner, local and global teams, and external contractor team in a very dynamic and strongly developing area of innovative medicine. Provide overview or detailed proactive communications to process owner, APR/PQR stakeholders, and global APR/PQR teams.Gain experience in leadership by leading a team of contractors.Lead through the review and on time completion of APR/PQR by collaboration with cross-functional teams.Act as an SME on APR/PQR during inspections and audits.Conduct, execute and document thorough investigations, CAPAs and Audit responses.Ensure timeliness of results through independent, proactive intervention.Act as a back-up for projects related to Change Control/NC/CAPA/Metrics.Bring forward innovative process improvements to drive compliance and/or efficiency and implement improvements as part of the global APR/PQR community.Contribute to continuous improvement projects in regards to standardization and simplification.Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.Review and approve compliance records, procedures and other documents, as required by procedure.Identify, support assessments and document issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations.QualificationsA minimum of a Bachelor’s Degree is required, preferably in Engineering, Chemistry, Biology, Biological Sciences or Food Sciences field.A minimum of five (5) years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic Production is required.Alternatively, a minimum of a laboratory technician EFZ degree, preferably with HF certification and a minimum of seven (7) years of experience in and outside of Quality Control with increasing responsibility.Proven ability to lead and influence others with very good communication and presentation skills.Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.Demonstrated skills in Process Excellence preferredStrong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.Job Field: Quality SystemsOrganization: Cilag AG (8562)