Job Description

Reporting to the Director of Quality Control, the QC Microbiology Manager provides strategic managerial direction and technical leadership for the Quality Control laboratory operations, ensuring samples are tested to GMP standards in a timely and efficient manner, to meet the needs of the business.
Duties include financial tracking, reporting and management of a significant budget, ensuring compliance with company policies, and managing and developing staff.
Manages Quality Control activities to ensure compliance with company standards, GMP and regulatory guidelines

• Ensures all testing (routine, project, investigational, validation) is completed in accordance with scheduled timelines and to relevant specifications/criteria
• Ensures teams engagement and collaboration through Site Management System (SMS), including Tier meetings, escalation processes and continuous improvement
• Oversees activities related to transfer/implementation of analytical methods/equipment
• Ensure handling of investigations is completed on time, and to the required standards. Providing technical guidance and decision making when required. To include management of out of specification (OOS) and deviation investigations, change controls, regulatory actions and closure of assigned corrective/preventative actions.
• Approves GMP-related data, to support batch release
• Ensures departmental standard operating procedures (SOP) are in place, up to date and relevant
• Engages and collaborates with enterprise initiatives and forums to share best practices and deliver improvements.
• Has oversight of department training, ensuring department is achieving necessary training KPIs
• Responsible for the operational management of the QC laboratories within remit of role, ensuring appropriate standards of cGMP, HSE, housekeeping and discipline are applied in the department in accordance with relevant regulations.
• Provides strong leadership and organisational planning skills. Responsible for mentoring and development of staff technically and professionally.
• Supports efforts across multiple areas to accomplish goals, providing guidance and influencing the organisation
• Provides strategic direction and in depth technical expertise, to include determining future resource needs, outsourcing and insourcing assessments, continuous improvement potential, and technical needs to be operationally excellent.
• Develops and cascades functional deliverables in alignment with the site objectives, providing clear vision of goals and tangible results
• Provides clear and effective communication (written and oral) to staff and external stakeholders. Interfaces across management levels and departments
• Acts as lead presenter during regulatory inspections for areas of responsibility
• Develops and delivers to schedule and budget. Responsible for budgeting, monitoring, forecasting, and reporting cost and schedule
• Provides strong leadership on safety and creates a positive safety culture. Ensuring safety is always on the front line
• Requires comprehensive understanding of concepts, theories and principles within own discipline and knowledge of others. Applies in-depth understanding of how own discipline integrates within the function. Identifies and resolves complex technical, operational and organisational problems
• Supports supervisors in understanding the development needs of direct reports, assisting them in accessing appropriate assessment tools and providing insight and guidance. Assists in constructing and executing compelling development plans for direct reports, shaping developmental roles and assignments to balance individual and business function needs
• Provides in depth, one-on-one coaching to enable team members to achieve performance goals and maximise their potential
• Sets stretching objectives and goals, creating an organised plan for distributing the workload across multiple teams in the function
• Ensures that employees within the function have the necessary skills and resources to succeed in tasks, resolving skill gaps by providing training and guidance
• Brings out the best in people by recognising and rewarding initiative, supporting decisions taken by others to guide work across the function

Qualifications

• Bachelor degree in a relevant scientific discipline (biology, microbiology, chemistry, etc.); advanced degree a plus
• Knowledge in Lean Principles/Continuous Improvement or a similar discipline

Capabilities

• 5+ years' experience in microbiological and biological, chemical or biochemical analytics in a biologics/pharmaceutical GMP environment
• 4+ management/demonstrated leadership experience
• Knowledge of test methods, method validation, regulatory guidelines that apply to our industry
• Knowledge/demonstration of exposure to external regulatory health authority inspections/audits

Please be advised this is a 12 Month Fixed Term Contract, internal candidates are invited to apply aligned to Secondment principles
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .
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Skills Required