Quality Manager, Investigations

Thermo Fisher Scientific•Whitby, ON

4d•CA$85,500 - CA$128,250•Onsite

About The Position

Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. This role provides 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. The Quality Manager will 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. This role is responsible for the on-time creation and issuance of Trend Reports to proactively identify trending issues.

Requirements

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy or a science related to pharmaceutical analysis
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.
Excellent interpersonal and leadership skills.
Extensive understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA.
Strong 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, PowerPoint).
Proficiency with the English language (oral and written).
Must be legally authorized to work in Canada
Must be able to pass a comprehensive background check

Nice To Haves

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

Responsibilities

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.
Accept Deviation Investigations and Complaint Investigations in order to initiate and lead the investigations.
Evaluate thoroughness of investigations and determined root cause(s).
Assign root cause and propose / assign Corrective Action Preventative Action (CAPA).
Follows up on Investigations and CAPA actions to ensure on time closure.
Monitor performance of Investigations and associated CAPAs through identification, monitoring, trending, and reporting of key performance indicators.
Drive continuous improvement of Investigations, adoption of standard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Site requirements.
Ensure Investigations related procedures are aligned to Corporate Quality Standards and Guidelines.
Attend client meetings as Investigations representative to provide guidance and strategic approach when 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 and initiation Trend Investigations unless there is an action plans in place to address them.
Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the Investigations team. Talk to auditors during inspections to ensure information is provided in a timely, accurate and complete manner.
Perform as Site System Owner for Trackwise related 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.