Brookfield

We are currently looking for a

Commissioning & Qualification Center of Excellence (CoE) Strategy Lead

The Commissioning & Qualification (C&Q) Center of Excellence (CoE) Strategy Lead role leads the overall execution of the commissioning, qualification and validation efforts regarding initiation, budgeting, scheduling, implementation, monitoring and closure according to requirements for capital investments of facilities, utilities, equipment, analytical equipment and computerized manufacturing systems. The C&Q CoE Strategy Lead works closely with project design leads and project delivery teams to implement the overall commissioning, qualification and validation strategy aligned with standard work developed by the Center of Excellence. The C&Q CoE Strategy Lead is responsible for the planning and execution of multiple projects and resources. The main objective is to execute project manager role for the commissioning, qualification and validation scope of capital investments. The position requires extensive interaction with project teams to work towards strategic delivery and execution that meet schedule, cost, and quality expectations and requirements. The C&Q CoE Strategy Lead takes a proactive role in supporting projects and providing support by building a high level of trust with internal and external stakeholders. 

Responsibilities:

• Vendor & contract management: Develop contractual strategy and framework to lead vendors, contractors, and corresponding contracts in assigned work to deliver commissioning, qualification and validation strategy.
• Coordinate external contracted project resources and third parties/vendors for the flawless execution of commissioning, qualification and validation project activities.
• Supervises/coordinates work of contractors in the execution of project activities.
• Participate/lead regulatory surveillance and benchmarking initiatives to stay abreast of changes in regulations that affect impacted processes and to identify new ways of working and evolving technologies.
• Maintains global expertise through ongoing training and participation in industry forums.
• Effectively manages complex commissioning, qualification and validation projects to ensure adherence with project timelines and budgets. Execute leadership role in managing/coordinating project activities. Delegate’s responsibility to project team contractors, as applicable.
• Provide C&Q leadership for multiple global projects, leveraging the knowledge and standard work developed by C&Q CoE SMEs.
• Perform project risk assessment (related to C&Q activities), plan/coordinate project resources, develop project-commissioning plan/strategy, and implement project execution/management standards.
• Strategy & organizational development: Prepare reports with key KPIs, support internal and external audits, and implement sharing/ leveraging of best practices and expertise in Commissioning and Qualification.
• Working knowledge of scheduling software and systems, and inventory management systems. Establish and maintains detailed project plans.
• Collaborates with project delivery team, SMEs and TT&V Validation representatives on project timelines, deliverables, activities and issue resolution.
• Establish and maintain communication plan within the project commissioning, qualification and validation team (meetings, minutes, maintain project action items) and provide routine project updates.
• Integrate CQV into the project lifecycle, working with other disciplines, both internal and external.
• Partner with project delivery and site teams to ensure successful project handover through start-up and operations.
• Review of CQV deliverables generated by project team members. Effectively interfacing and communicating with 3rd parties, client and CQV project teams.
• Assist in development and maintenance of a global center of excellence with best practices, strategies and framework for commissioning and qualification based on current regulations, industry standards and industry practices for biopharmaceutical products.
• Promote innovative and efficient approaches to C&Q incorporating risk-based elements and considerations unique to biopharmaceutical production. Implement risk management tools and techniques to ensure the appropriate prioritization and level of rigor to qualification activities.
• Prepares Commissioning/Qualification Project Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents according to procedures and requirements, as needed.
• Function as owners of C&Q catalog-based project playbook.
• 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.

Qualifications:

• Degree in Engineering, life sciences or other related technical field, combined with 7+ years working experience in commissioning and qualification in a regulated industry (i.e. GxP manufacturing / research and development) with a broad-based understanding of pharmaceutical manufacturing and overall business processes.
• Good communication and conflict management skills to influence technical experts and stakeholders at all levels in the organization.
• Significant commissioning and qualification experience in Pharmaceutical / R&D projects.
• Significant fill/finish experience.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Working understanding of lean processes principles.
• Comprehension of Industry and Regulatory Authorities Regulations related to Biopharmaceutical Facilities including FDA, EMA, ICH, ASTM, ISPE, TGA, etc.
• Excellent planning, organizing, analysis and problem solving skills. Strong background and understanding in the planning and execution of projects.
• Familiarity with Commissioning and Qualification Processes, Tools & Systems utilized within the industry.
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Ability to operate in a matrix organization.
• Understanding of scheduling fundamentals and execution.
• Ability to work in a fast-paced environment, organized and able to prioritize tasks to meet multiple deadlines.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Experience in Heating ventilation and air condition (HVAC) a strong asset.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!