Project Leader II - Quality

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Manage a portfolio of Clients and updates quality plans/quality performance for clients, supports product transfers from Pharmaceutical Development Services (PDS) and external to Commercial operations. Provide on floor Quality (Q) support, and approves deviation/OOS/OOT investigations, validation protocols/reports, change controls, technical transfers. Lead Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data.

What will you do?

Manage multiple small-medium projects and/or improvement initiatives

Lead risk analyses

Assure continuous Quality improvement in plant related to trends from Quality systems

Lead Quality initiatives, and provides Q support throughout the facility, quality assessments on process improvement activities such as Mini Ts, Kaizens

Work with management to resolve project issues and resource constraints within the team.

Support decision making on projects and future directions by trending deviations in Track Wise (TW)

Maintain positive team member interactions and manages conflict with assistance from Senior Quality Assurance Manager

Plan, monitor, and ensure completion of Metrics, CAPAs and quality approvals

Quality approvals and timely review of DRs/OOS/OOT, validation protocol/reports, change controls, technical transfers

Facilitate content of Quality Huddles, represent Quality at RAPIDs, and material under investigation

Prepare Quality Agreements for approval

Assure GTW compliance

Manages client satisfaction by updating quality plans and coordinates customer requests

Manage a portfolio of Clients of moderate to high complexity and will be the key contact

Monitor Voice of the Client (VOC) and builds improvement plans

Prepare quality presentations for Client meetings and present

Support PAI or Client audits as necessary

Write Quality Agreements

Provide QA Support for Technical Transfer Team and new equipment implementations

Act as QA Liaison for technical transfers (change controls; DRs; technical packages; gap analysis)

Maintain a safe working environment and report potential hazards.

Perform alternating or rotating shift work (as required)

How will you get here:

Education:

College/Technical School Diploma in related field

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Engineering an asset

Experience:

Minimum 6 years of previous related experience in pharmaceutical/food/cosmetic industry, preferably in a QA function.

Minimum 2 years pharmaceutical development experience

Project management experience or client management experience

Client interface experience and strong negotiating skills

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Strong self-motived individual. Ability to work independently, and within a teamenvironment. Well organized and detail oriented with the ability to meet deadlines. Ability to prioritize multiple tasks. Strong interpersonal skills. Solid knowledge of Good Manufacturing Practices. Established quality, regulatory, and production mentality including an appreciation for client service and the contract manufacturing industry. Excellent written, oral communication and presentation skills. Proficiency using MS Office applications. Proficiency with English language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

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