Manager, Qc Operations

2 weeks ago

Brisbane, Australia Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

***

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. The Quality Control Laboratory is responsible for the execution of Qualification/Validation Protocols. Technical Transfer (as applicable) and Performance for Quality Control tests undertaken within the Quality Control Laboratory.

The QC Operations Manager will lead the Quality Control Operations teams, including:

- QC Biochemistry
- QC Chemistry
- QC Physiochemistry
- QC Microbiology
- QC Training and Support Team

Responsibilities include assuring timely and scientifically sound output for the Quality Control Operations teams according to International regulatory guidelines related to assay qualification/validation, in-process production samples, final formulated products and systems with International quality requirements, and in line with the customer specific requirements.

**Key Responsibilities**:

- Responsible for developing and leading the QC Operations team and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
- Responsible for QC Operations team resource management and for initiating timely resource planning for the QC Operations team based on production forecasts and business needs.
- Ensure own and teams plans, targets and objectives are optimally monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF
- Manage completion of GMP documentation to the required standard and timescales, to ensure timely and efficient service for our internal and external clients
- Monitor and be responsible for the Test Record review process, including customer concern of issues and driving completion of quality records e.g. OOS, Deviations, Investigations, CAPA and Change Controls.
- Drives and owns a quality mentality of the team by facilitating the desired ‘way of working’, quality culture and the 4i values through actions, coaching and mentoring
- Proactively drive and react to system trending (e.g. deviations, complaints) to ensure ongoing quality performance.
- Act as primary QC Operations representative during Regulatory Inspections and audits (e.g. client and corporate)
- Embrace and actively drive Practical Process Improvements (PPI) and performance by seeing opportunities to improve quality/compliance, reduce cycle time, and increase operational efficiency.
- Partner with key customers to prioritize projects aligning with the quality goals and objectives
- Ensure that own, and teams work aligns with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, Protocols, Guidance’s, etc.
- Ensure own, and teams training is undertaken in a timely and GMP compliant manner before the task is undertaken and maintain an updated and compliant training matrix for the team
- Support and encourage a “Quality Culture” and company 4i values
- Perform any other legitimate duties as directed by the Head of QC.

**Frequent Contacts**:
Internal
- All Internal Departments including QC, QA, Operations, Engineering, Validation and Supply Chain

External
- Customers
- Regulatory Agencies
- Other Thermo Fisher Scientific Business both within and external to the PSG
- Equipment/Contract Laboratory/Maintenance vendors and contractors

**Minimum Requirements/Qualifications**:
Qualifications & Experience
- Bachelor of Science (Biotechnology, Chemistry, or closely related degree).
- Post Graduate qualifications - beneficial.
- At least 3 year of experience in a leadership role in the pharmaceutical and/or pharmaceutical industry.
- Expertise with method transfer, qualification or validation and execution.
- Knowledgeable in cGMP practices.
- Knowledgeable with various QC laboratory analyses, efficient sample workflows, in process controls and analytical testing, and area/equipment within the Quality Control Laboratories.
- Strong background in analytical theory and technical competency with laboratory analysis.
- Ability to work in a highly dynamic, frequently changing environment with a wide var

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