Senior Director, Quality Control Operations
Vor 4 Tagen
We are seeking a highly experienced Senior Director, Quality Control Operations to lead our global quality control organization. The successful candidate will be responsible for managing and directing quality control processes and procedures to ensure compliance with regulatory requirements and corporate standards.
Key Responsibilities- Lead best practice global Quality Control processes and procedures.
- Drives global QC processes and procedures consistent with regulatory requirements and corporate standards.
- Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
- Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting.
- Ensure collaboration across the CSL network to share and implement best practices.
- Provide Quality Control Execution and Oversight.
- Collaborate with partners to enable compliant, timely and successful quality control testing ensuring all program and corporate goals are met.
- Partner with all functions to proactively identify and mitigate Quality Control issues / concerns.
- Oversee the operations of all Quality Control activities globally for testing activities.
- Lead and/or review key global laboratory deviation evaluation and resolution activities as required.
- Continuously improve quality control processes to reduce cost and improve quality.
- Collaborate with business partners including quality's corporate quality leaders, manufacturing site functional leadership, global supply chain leadership, R&D, and others to identify improvement opportunities across the organization.
- Optimize in-process and final quality control/inspection efficiency.
- Work with operations leaders and team members to define the implementation strategies for continuous improvement across the organization.
- Develop appropriate tools and methods to sustain improvements across the organization.
- Provide Quality Control team leadership.
- Provide leadership and guidance to a global Quality Control site heads to effectively execute on Quality Control strategies and programs.
- Set objectives and provide clear direction for execution.
- Responsible for organizational design and staffing decisions. Recruit, retain, train, and develop the Quality Control team.
- Quality Issue and Risk Management.
- Lead proactive risk assessments to identify and mitigate quality control issues.
- Represent CSL during audits and inspections, as needed.
- Ensure inspection readiness across the QC network.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Advanced degree (Master's) in life sciences field; PhD preferred.
- Minimum of 12 years' experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
- Minimum 10 years of managerial experience.
- Experience working in a highly regulated GMP environment as it applies to laboratory and stability functions.
- Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
- Experience with testing methods and processes including raw materials testing, stability testing, and sample management.
- LEAN experience, preferred.
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Bern, Bern, Schweiz CSL Behring Vollzeit{"h2":{"text":"Senior Scientific Expert Quality Control Support"},"p":{"text":"At CSL Behring, we are seeking a highly skilled Senior Scientific Expert Quality Control Support to join our team in Bern. In this role, you will be responsible for supporting the Quality Control activities and projects within Quality Control Bern, reporting directly to the...
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