Process Leader (Secondary Manufacturing) 13 Month FTC - #1689448

The role is the Operations Manager for Secondary Manufacturing (drug product) department responsible for providing leadership of the operations teams through daily, weekly, monthly management processes.

Providing the right level of recruitment of the team, contributing to the process/operational inputs to projects, delivering the agreed manufacturing organization to operate the facility compliantly.
The Process Leader has first line accountability for identifying efficient ways of working in the area of responsibility and with the associated team.
Works with the Head of Secondary Manufacturing (Formulation, Filling, Inspection and Packaging) to interpret and set the strategy and to set targets for area performance in Quality, Service, Cost, Safety and People development.

The role holder will assume responsibility for all aspects of the operations, supporting budgeting, CAPEX programme development and driving
product improvement initiatives.

Responsibilities

• 
  Product - Direct Manufacturing activities to deliver customer needs and achieve financial target, in compliance with all regulatory standards. Support and oversee maintenance programs, inventory controls and validation activities.


• 
  People - Plan and execute talent management, development activities and skills training for all of the teams in collaboration with local functional managers. Drive engagement and provide leadership to ensure an effective organisation focussed on safety, quality, customer deliver and cost. Appraise area performance against objectives and communicate progress to senior management. Manage the recruitment and development of direct reports.


• 
  Quality - Ensure all manufacturing activities comply with FDA, EU and other regulatory authorities, relevant Acts, legal demands and CSL’s code of conduct. Ensure product and facility compliance of all regulatory bodies in all target markets with a focus on FDA and EU compliance. Oversee the ongoing education and development of employees in GxP and other Quality topics


• 
  Safety - To lead, motivate and coach the manufacturing team to achieve a culture of HSE excellence, maintain and improve area standards and performance.


• 
  Operational Excellence - Drive a culture of risk-based continuous improvement across manufacturing area to drive a lean manufacturing operation. Identify and prioritise key performance improvements within area.


• 
  Cost - Develop and deliver budgets. Continuously review and improve ways of working to maintain global competitiveness as a manufacturer of vaccines.


• 
  Communication - Provide accurate and timely management information to Head of Secondary Manufacturing, onsite and off-site stakeholders. Escalate issues and proactively manage internal and external stakeholder relationships.


• 
  Strategy - Fully contribute to the development of manufacturing area and support the development of Secondary Manufacturing as a member of the extended Leadership Team

Education Requirements

You are likely to be a graduate or be able to demonstrate experience to this level.

Experience Requirements

• You will have extensive experience leading pharmaceutical/chemical manufacturing operations teams.




• Vaccines/Biological cGMP technical experience is preferred




• Regulatory experience to be capable to support FDA and MHRA inspections.

This is a 13 month fixed term contract / secondment opportunity

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

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

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus