Supervisor, Complaints Investigations

APOTEX; Richmond Hill; On-site; CAD 84,000 - 140,000; Full time

Benefits offered by this job

Bonus programs

Comprehensive benefits

Job summary

Apotex, a Canadian-based global health company, seeks a site supervisor of Complaint Investigations at the Richmond Hill manufacturing site. You will supervise investigators, ensure investigations are conducted in line with GMP and SOPs, and drive timely root cause analysis and corrective actions.

The role requires a BSc in a related field, 7+ years in pharmaceutical QA, proficiency with SAP and Trackwise, and strong leadership and communication.

Qualifications

• BSc in Chemistry, Biology, Engineering or related field.
• Strong GMP knowledge and QA oversight of deviations and complaints.
• 7+ years in the pharmaceutical industry in Quality Assurance.
• Proficiency with SAP and Trackwise.
• Excellent English written and verbal communication.

Responsibilities

• Ensure all complaint investigations are investigated and documented per GMP and site procedures.
• Develop and implement systems to improve complaint workflow and effectiveness.
• Coordinate cross-functional efforts for investigation, root cause, and corrective actions.
• Manage data collection, analysis, and reporting of complaints and trends.
• Mentor and coach a team of complaint investigators and supervise workload.

Skills

Organizational skills

Interpersonal communication

English proficiency

Time management

Education

BSc in Chemistry

BSc in Biology

BSc in Engineering

Tools

SAP

Trackwise

Job description

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Responsible for supervising Project Leader Complaint Investigators and the Coordinator Complaints processes at Richmond Hill manufacturing site in accordance with Regulatory requirements and Standard Operating Procedures (SOPs). Responsible to ensure that all complaint investigatoins are properly investigated in a timely and effective manner leading to root cause and corrective action determination. Oversee generation of complaint investigation metrics, ensure complaint investigations sustainably achieve metric targets, trend reports are completed on time, and action plans are created for identified trends to mitigate risk. Responsible for supervising, developing, and coaching a team of complaint investigators.

Job Responsibilities

• Responsible to ensure all complaint investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP’s.
• Develops and implements systems for improving complaint workflow and effectiveness.
• Works at intermediate and senior levels across the site and organization to ensure effective complaint investigation, root cause determination and appropriate corrective actions and preventive actions are identified.
• Responsible for complaint investigation data collection, analysis, and reporting for monitoring of complaint investigation performance and trend reports to be reported out at the Site Management Review.
• Responsible to manage escalation of complaint investigations and to mitigate risk by working with impacted departments to come to an agreement on a path forward.
• Analyzes complaint data and proactively identifies emerging trends and proposes measure to correct them.
• Leads, oversees, or participates in cross functional projects associated with complaint investigation reduction initiatives.
• Directly supervises a team working to investigate and close complaints.
• Coaches, mentors and trains staff to ensure that complaint investigations are of high quality, identify root cause and meet all GMP requirements.
• Facilitate daily huddles and weekly review boards to drive the performance of complaint investigations as required.
• Responsible to maintain site procedures for complaint investigation in alignment with corporate, global, and regulatory requirements.
• Responsible for supporting Regulatory Inspections, Corporate Audits, Client Audits, and Self-Inspections as the Complaint Investigation process and procedure owner.
• Provides performance management of direct reports providing ongoing feedback.
• Supervises the teams’ workload and ensures balance across the group, re-distributing activities as required.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education
  • BSc in Chemistry, Biology, Engineering or a related field.
• Knowledge, Skills and Abilities
  • Superior organizational, interpersonal communication skills including technical writing.
  • Ability to manage time effectively.
  • Ability to work independently and manage multiple priorities in a fast paced and changing environment.
  • Excellent command of the English language, both written and verbal.
  • Extensive knowledge of GMP requirements.
  • Proficiency with Word, Excel, SAP and Trackwise software.
• Experience
  • Minimum 7 years' experience in the Pharmaceutical Industry in Quality Assurance
  • Experience with quality oversight of Deviation and Complaint Investigations, Root Cause analysis tools, and Regulatory Audits

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $83,958 - $139,930 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.