Manager, Qc Operations

Job Description
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.
Position Summary:
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 variety of people and perspectives.
• Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
• Ability to work on multiple projects simultaneously.
• Strong team-working and collaborative skills.
• Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).
• Good knowledge of Laboratory Information Management Systems (LIMS) – desirable.
• Good knowledge of Smartsheets – desirable.

Skills & Attributes

• Adaptability: Ability to adapt to day to day business requirements.
• Collaborating: Demonstrates the ability to work with all departments and colleagues of varied backgrounds.
• Continuous Improvement: Demonstrates the ability to challenge the status quo to drive PPI.
• Customer Focus: Demonstrates the ability to deliver on promises made to customers i.e. meet agreed timelines.
• Initiating Action: Demonstrates the ability to work independently and manage planned work. Ability to work on multiple projects or tasks simultaneously.
• Managing Relations: Demonstrates the ability to manage customer demands with respective business requirements and agreed timelines.
• Quality Orientation: Ability to interpret and apply cGMP principles and strong attention to detail. Strives for right first time in every task undertaken. .

Other Job Requirements:

• Provide industry-leading customer experience.

• Be the highest quality, most efficient and flexible provider.

• Deliver the best technical and scientific solutions to enhance product value.

• Create a culture of engagement, accountability and a shared commitment to excellence.

• Operate our business in a compliant, safe disciplined, responsible, and ethical fashion.

• Abide by all EH&S policies and procedures.

• Work safely and only perform tasks if currently competent and/or authorised.

• Report hazardous conditions, hazardous actions, and incidents and near- miss incidents.

• Participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.

• Not knowingly pollute the environment.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.