**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Division/Site:**
Our Whitby Site specializes in commercial manufacturing (https://www.patheon.com/us/en/our-capabilities/small-molecule/oral-solid-dose.html)
for a full range of conventional dosage forms (https://www.patheon.com/us/en/our-capabilities/small-molecule/oral-solid-dose.html)
with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.
**Discover Impactful Work:**
Provide direction to the functions within Investigations in accordance with Regulatory and Corporate Quality Standards & Guidelines: Deviation Investigations, Complaint Investigations, and Corrective and Preventive Actions to prevent recurrence.

Manage the daily activities of the Investigations staff to create a culture of quality awareness and teamwork, while coordinating investigations and working with the appropriate parties to complete product Deviation Reports (DRs) and Complaint Reports.

Responsible for on time creation and issuance of Trend Reports to proactively identify trending issues.
**Day in the Life:**
Manage the team responsible for Site and Product Investigations: Deviations and Complaints
Direct and prioritize the Investigations team to ensure regulatory requirements, client commitments, and production needs are met.

Coach on the Investigation process writing quality investigations.

Assist in training and development of Investigators, providing performance feedback.

Removes barriers
Mentor the team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site.

Investigation Report Process: Accept

Deviation Investigations and Complaint Investigationsin order to initiate and lead the investigations.

Evaluate thoroughness of investigationsand determined root cause(s).

Assign root cause and propose/assign Corrective Action Preventative Action (CAPA).

Follows up on

Investigations andCAPA actionsto ensure on time closure.





Monitor performance of Investigationsand associated CAPAsthrough identification, monitoring, trending, and reporting of key performance indicators.

Drive continuous improvement of

Investigations, adoption ofstandard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Siterequirements.

Ensure

Investigationsrelated procedures arealignedto Corporate Quality Standards and Guidelines.

Attend client meetings as

Investigationsrepresentativeto provide guidance and strategic approachwhen required.

Host and facilitate daily huddles and weekly review boards in support of driving the performance of

Investigations.

Ensure timely issuance of Quarterly

Investigations

Trend Reports to proactively identify trends andinitiation Trend Investigations unless there is anaction plans in place to address them.

Support

Regulatory Inspections, Corporate Audits, and Client Auditsspecific to the functions within the

Investigationsteam.

Talk toauditors during inspections to ensure information is provided in a timely, accurate and complete manner.

Perform as Site System Owner for Trackwiserelated to Investigations(i.e. support troubleshooting, provide support to end users.

Communicate issues that potentially affect product quality/compliance to the attention of Leadership.

Support special projects as assigned.

Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures.

Select, develop and evaluate staff to ensure the efficient operation of the function.

Work with and advise staff on administrative policies and procedures.
**Keys to Success:**
**Education:**
Bachelor of Science (B.

Sc.) in Chemistry,



Pharmacy or a science related to pharmaceutical analysis
**Experience:**
Minimum 8 years of experience within the pharmaceutical, food or cosmetic industry.

Minimum 5 years previous supervisory and/or leadership experience.

Minimum 5 years industry experience performing activities directly related to Investigations (Deviations, Complaints) and CAPAs.
**Equivalency**
_:_
Equivalent combinations of education, training, and relevant work experience may be considered.
**Knowledge, Skills and Abilities:**
Excellent interpersonal and leadership skills.

Extensive understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA.

Solid problem solving skills (identifying and evaluating root cause, and recommending corrective actions / preventative actions (CAPA).

Excellent organizational skills with proven ability to prioritize when timeline conflicts exist.

Detail oriented with a high degree of accuracy and thoroughness.

Ability to problem solve and troubleshoot.

Ability to carry out investigations in a non-threatening manner with production staff and to effectively interact with internal and external suppliers and clients.

Proficient Microsoft skills (Word, Excel, Power

Point).

Proficiency with the English language (oral and written).
**Excellent Benefits**
Benefits & Total Rewards | Thermo Fisher Scientific (https://jobs.thermofisher.com/global/en/total-rewards)
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
**OTHER**
Relocation assistance is NOT provided
Must be legally authorized to work in Canada
Must be able to pass a comprehensive background check
**Compensation**
The estimated annualized pay range for this position in Ontario is $85,500.00–$128,250.00.

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.

📌 Quality Manager, Investigations (Whitby)
🏢 ThermoFisher Scientific
📍 Whitby