Manager, Commissioning and Qualification
Posted on Feb 14, 2020 by CSL Behring
With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Responsibilities Manages and directs the daily activities and resources for Commissioning and Qualification (C&Q). Establishes and implements risk-based C&Q programs for equipment, utilities, facilities and processes; ensuring compliance with all applicable regulatory and internal Quality standards and industry best practices. This includes project scoping, financials, scheduling, tracking, and resource allocation. Interfaces with Engineering, Manufacturing, Facility Services, Utility Services, QA, QC, R&D, Regulatory and various outside contractors (Qualification, Process/Project or Controls Engineers). Qualifications
Main Responsibilities and Accountabilities:
- Develops and manages risk-based commissioning & qualification strategies, guidance, procedures, and policies for small to large scale multi-facetted projects; ensuring compliance with all applicable Regulatory and internal Quality standards, and industry best practices.
- Prepares department budget inputs, project cost estimates, timelines, and resource requirements.
- Prepares proposals and bid packages to secure contractor services. Tracks spending on approved contractor/project purchase orders.
- Provides oversight of C&Q project implementation strategy from inception to production implementation including aspects of project planning, training, resource management, execution logistics, close-out, and application of lessons learned.
- Maintains project risk avoidance measures and addresses escalated issues relating to C&Q studies, equipment, or procedures.
- Supports direct reports in effectively scheduling, coordinating, and communicating project activities with appropriate functional groups (ie Manufacturing, Engineering, QA Operations, QC Labs, etc.)
- Assists direct reports in the preparation and review or approval of C&Q deliverables (such as risk assessments, plans, design qualifications, specifications, requirements trace matrices, and protocols/reports), as required.
- Reviews C&Q-related Quality Management System deliverables including Deviations, Investigations, CAPAs, and Change Controls.
- Guides and develops C&Q personnel providing feedback, managing performance, maintaining bench strength, and ensuring appropriate compensation.
- Supports internal and external inspections including inspection readiness activities.
- Participates in leadership teams, governance processes, and review boards that assess or impact C&Q.
- Helps to manage department objectives, simply excellent initiatives, stakeholder expectations, all-staff communications, and key performance indicators.
- Foster a culture of continuous improvement while focusing on operational efficiency and the elimination of "non-value added" activities.
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by senior management.
- BS in Engineering, Physical, or Biological Science
- 6+ years of relevant cGMP experience in the pharmaceutical industry
- 3+ years of people management experience
- Proven demonstration to perform in the role may also be considered
- Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing
- Familiarity with regulatory/compliance environment (cGMP, USP, EP, ISPE, PDA, and ICH) associated with aseptic parenteral drug manufacturing
- Working knowledge of Quality Systems especially as it relates to deviations, change control, CAPAs, OOS, and risk management
- Demonstrated experience managing Validation systems in a pharmaceutical manufacturing company and exceptional knowledge of cGMP
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; problem solving analytical/conceptual thinking, and a strong work ethic
- Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects
- Customer Focus
- Attracts and Develops Top Talent
- Drives Results
- Plans and Aligns
- Decision Quality
- Dealing with Ambiguity
- Conflict Management
- Optimizes Work Processes
- Networking and Interpersonal Saavy
Worker Sub Type:Regular
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