Regional Quality Assurance Manager
vor 4 Wochen
We are seeking a highly experienced Regional Quality Assurance Manager to join our team at CSL Behring. This is a critical role that will involve managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and providing quality oversight for outsourced operational activities.
Responsibilities- Quality Oversight
The successful candidate will be responsible for ensuring that CMOs meet the required quality standards, including regulatory compliance and product quality. This will involve developing and enforcing Quality Agreements, supporting CMO Changes and Deviations, resolving quality issues, and reviewing Quality Performance KPIs.
Collaboration and Relationship ManagementThe Regional Quality Assurance Manager will establish collaborative relationships with CMO and MAH stakeholders to ensure strong business partnerships and resolution of issues. This will involve serving as the primary regional interface and point of communication for assigned CMOs, partnering with CMO and MAH stakeholders to ensure strong business partnerships and resolution of issues, and striving for business continuity in partnership.
Performance Monitoring and ReportingThe successful candidate will be responsible for overseeing, tracking, and reporting on regional CMO quality performance. This will involve developing, monitoring, and reporting CMO Quality performance through globally aligned KPIs, identifying CMO issues that present a trend, and ensuring adequate corrective actions are implemented at the CMO.
Escalation and ResolutionThe Regional Quality Assurance Manager will escalate quality issues during Joint Operation Meetings, escalate quality issues and emerging trends to Sr. Manager, CMO Quality, key stakeholders, and relevant global functions, and ensure that all required operational areas are fully aware of results and progress to ensure MAH can validate to root cause investigations and CAPAs.
Standardization and GovernanceThe successful candidate will maintain standardized Quality Oversight processes with CMO and CSL Sites, act with applied consistency of CMO Quality process and governance, drive the integration of the CMOs to CSL's quality system governance by striving for harmonization across quality system handling, and follow standardization across CMOs to ensure comparability between CMOs.
Representative and LiaisonThe Regional Quality Assurance Manager will represent QA in cross-functional project teams such as CMO Operations, commercial readiness, and process improvements, acting as the SME for CMO Management organization in the dedicated cross-functional CSL teams, participating and representing Quality at joint Operational Meetings, preparing the quality content for the Joint Business Review Meeting, leading Quality related topics at off-site visits and teleconferences for discussion and review of CMO performance and cGMP compliance, and leading Quality related sub-projects within CSL and in connection with the corresponding relationship.
On-Site Presence and SupportThe successful candidate will provide on-site presence as necessary, lead the on-site resolution of Quality concerns at CMO Operations and CMO Commercial readiness phase, enhance CMO Quality Maturity, execute Quality Road Maps as necessary, support CSL Product related regulatory inspections at the CMO as needed, assess and communicate any potential impact on CSL business, and support Regulatory Observations related to CSL product as necessary.
Requirements- Education and Experience
A B.S. degree in a relevant business or science field, or equivalent education and experience, with a minimum of 5 years' experience in a GxP environment in the pharmaceutical industry.
Regulatory Knowledge and SkillsA thorough understanding of required regulations, including but not limited to FDA, PiC/S, and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc., strong industry and quality system knowledge (internal and external) experiences within the industry, and the ability to work in a global, matrix organization.
Language SkillsFluent in English and German (written and spoken).
Estimated Salary Range$120,000 - $180,000 per year, depending on experience.
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