COMPLETE Validation Lead - APAC, AU, Broadmeadows, CSL Behring

Summary:

The Site Validation Lead oversees the team accountable for planning and executing process and cleaning validations, ensuring compliance with company standards and governmental regulatory requirements; considering adequate risk-benefit aspects; investigating and troubleshooting validation problems. S(he) is also accountable to provide adequate resourcing for validation activities. S(he) is the main point of contact to the Center of Excellence (CoE) Validation group and assists with establishing corporate validation policies on site. 
This role manages a small to mid-sized team which may consist of both experienced professionals and managers. S(he) supports and understands validation needs for both projects as well as routine validation activities and focuses on policy and strategy implementation for short to mid-term results (e.g., 1-2 years). Requires ability to influence others to accept practices and approaches, and ability to communicate outside own functional areas. Problems faced are often complex and require extensive investigation and analysis.
 

Responsibilities:
• Assessment of validation requirements for changes and projects 
•    Responsible for providing validation support and staffing for projects 
•    Accountable for ensuring that all manufacturing processes on site remain in a validated state, including cleaning processes
•    Responsible for providing adequate staffing for routine/regularly recurring validation activities
•    Oversees writing and reviewing of documents for required registrations and providing adequate responses to regulators regarding validation topics
•    Responsible for leading and performing process risk assessments for the site manufacturing processes using defined risk management tools
•    Responsible for providing input to deviations related to validation activities: support of the root cause analysis and CAPA definition as required
•    Identification and closure of validation gaps on site to minimize compliance risks
•    Key point of contact in inspections for all validation related topics
•    Accountable for tracking key validation KPIs on site

•    Liaises/aligns with the other site teams and the CoE on validation topics
•    Responsible for providing input to and agreeing on new or changes to relevant validation concepts, procedures, policies, standards
•    Responsible for applying validation procedures to ensure compliance with global standards and regulatory guidelines 
•    Defines the validation strategy and the validation effort required for registrations (new license applications, extension of registrations, changes) in close collaboration with the CoE
•    Ensures the implementation and execution of the defined validation strategy considering optimization of costs and effort (e.g. with innovative and risk-based approaches)
•    Drives continuous improvement and innovation for validation processes on site in close collaboration with the CoE

•    Communicates and manages implementation of validation concepts and standards on site
•    Defines and communicates site validation objectives to ensure adequate prioritization, planning and timely execution of validation activities
•    Responsible for defining the long-term staffing strategy based on the validation requirements in collaboration with the PE site head
•    Establishes performance goals and strategic/operational objectives for direct reports
•    Coaches, counsels, and appraises performance of personnel.
•    Develops staff competencies & capabilities to enable sustained success and career development.
•    Promotes high employee engagement and a positive work environment.
•    Establishes and maintains a culture of learning and continuous improvement through capturing lessons learned and networking
•    Responsible for budget resource requirements and staffing decisions in collaboration with the PE site head
•    Promotes customer focus within the site validation team and collaborating with stakeholders in the Value Streams, QC, Process Engineering, QA, Regulatory Affairs and other functional areas.

Competencies:

•    Customer Orientation (Internal/External): Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.

•    Drives results: Consistently achieving results, even under tough circumstances. Has a strong bottom-line orientation and persists in accomplishing objectives despite obstacles and setbacks. Has a track record of exceeding goals successfully. Pushes self and helps others achieve results

•    Collaboration and Influencing: Champions a culture of inclusiveness and teamwork. Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.

•    Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

•    Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

•    Develops talent: Developing people to meet both their career goals and the organization’s goals. Places a high priority on developing others. Develops others through coaching, feedback, exposure, and stretch assignments
 

Qualifications:
• Degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred

•    8+ years’ experience in pharmaceutical manufacturing quality or operations management in a cGMP environment; 3+ year’s validation experience
•    Leadership/management experience
•    Knowledge and experience with biologicals and aseptic processing
•    Knowledge of current regulations and guidelines, industry standards and best practices for validation of biopharmaceutical products
•    Knowledge of quality by design principles and tools
 

Please attach you resume. Applications will close on 21 November 2023.

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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