Manager, Quality Assurance - Jobs in Milton

Job Description

Are you looking to make a difference in a patient’s lifeAt AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!What you will be doingWhy choose Innomar Strategies

• “Remote-First” culture – flexible opportunities to work from home!
• Competitive Total Rewards Package:
  • Base salary + bonus programs
  • RRSP matching
  • Employee Share Purchase Plan
  • Flexible benefits program (in effect on day one), including:
    • Healthcare Spending Account
    • Wellness Account – to focus on your nutrition, fitness, health and well-being
• Parental Leave Top Up, 24/7 Employee Assistance Program, and Virtual Healthcare
• Tuition Reimbursement + Employee Referral Programs
• Growth opportunities for career advancement
• Learning Programs, Leadership Training and Mentorship Programs to further your professional development
• Ability to make an impact in creating healthier futures
• We value diversity, equity and inclusion to foster a culture of belonging

PRIMARY DUTIES AND RESPONSIBILITIES:

• Ensure that all Quality Assurance release activities associated with 3PL operations are completed in compliance with the GMPs and in accordance with contractual obligations.
• Manage a team of QA Release Specialists and Associates, assigning day to day activities and providing regular direction, mentoring, and coaching to the team.
• Develop effective relationships with Operations Management in order to ensure that the Milton Warehouse and Innomar DCs are maintained in a state of GMP compliance.
• Actively contribute to the development, maintenance and improvement of the Innomar GMP Quality Systems.
• Act as primary host for client audits, including preparing the formal responses, and provide support during regulatory inspections and corporate audits.
• Execute the internal audit program and ensure that any adverse trends are communicated to senior QA management.
• Provide support to the Senior Manager, QA GMP with management of both the deviation program and the change control program.
• Prepare quarterly trend reports for key quality indicators and present these trends to Management.
• Provide support to the Senior Manager, QA GMP for Product Recalls, including customer notification, coordination of customer returns and maintaining documentation.
• Ensure that Mock Recalls are run annually to meet GMP requirements for Drugs, NHPs, and medical devices, within all inventory management systems utilized at Innomar.
• Administer the vendor management program including the review, evaluation and approval of service providers.
• Support the facility and equipment qualification programs, which includes temperature mapping of the warehouse, refrigerators and freezers, execution of lane studies, and validation of pack-outs.
• Provide leadership and direction to the QA team in the absence of both Senior Manager, QA GMP.
• Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required.
• Understand and apply company Confidentiality and Privacy Agreements.
• Travels up to 20% of the time.
• Other duties and tasks that may, from time to time, be assigned by Senior QA Management.
• May be required to be on standby/ on call as part of this role.

What your background should look like EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Bachelors of Science degree in a pharmaceutical or healthcare related field (e.g. chemistry, microbiology, pharmacy, and pharmacology).
• Minimum of 6 years’ experience in Quality Assurance.
• Experience in conducting vendor audits.
• Experience in hosting/co-hosting client audits is considered an asset.
• Experience working in an Operations/Warehouse environment is considered an asset.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to manage risk in a quality operations environment.
• Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
• The ability to identify pragmatic solutions to compliance/operational problems and challenges.
• Demonstrated leadership, organizational, inter-personal, and communication skills (verbal and written), with a proven track record conflict management.
• Proven ability to organize individual and team workloads, set priorities and multi-task in order to meet competing deadlines, with the ability to remain flexible, adaptable and responsive to changing business needs.
• Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications/platforms (e.g., eQMS, EMS, WMS, CRM, etc.).

What AmerisourceBergen offersWe offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.ScheduleFull time Affiliated Companies:Affiliated Companies: Innomar Strategies Equal Employment OpportunityAmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.COVID-19 Vaccine PolicyAs of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation.Accessibility Policy AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.