Quality Assurance Manager

Job not on LinkedIn

🔥 2 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Lead and assign the day-to-day work of Sr. QA Specialists • Provide direction, coaching, mentoring, training and cross-training • Perform hands-on quality activities and own complex or high-impact assignments • Maintain importer Drug Establishment Licences and manage foreign site approval processes • Ensure compliance with Health Canada regulations and guidance for drug, medical device and natural health product importation • Perform or oversee release of commercial drug products and clinical trial supplies to the Canadian market • Maintain and review SOPs, annual product quality reviews, stability reports, qualification and validation documentation, artwork and temperature studies • Ensure deviations, CAPAs, product quality complaints, change controls and trend analyses are completed compliantly and on time • Provide expert quality consultation to clients through risk assessment and practical solution recommendations • Contribute to development, maintenance and continual improvement of GMP quality systems • Advise departments on Quality Assurance requirements, risks and strategies • Support or lead internal, client, third-party and regulatory audits or inspections • Support recall and mock recall activities • Build relationships with stakeholders, clients, foreign sites and external partners • Participate in client meetings and presentations and communicate Quality positions • Manage multiple projects and deliver work within established timeframes • Deliver training, presentations and seminars to internal teams, clients and external organizations • Complete or support invoice reconciliation and quotation activities • Comply with confidentiality and privacy requirements • Perform other duties assigned by Senior QA Management

🎯 Requirements

• Bachelor's degree in a pharmaceutical, scientific or healthcare-related field, such as chemistry, biology, microbiology, pharmacy or pharmacology • Minimum 10 years of Quality Assurance experience in a regulated pharmaceutical or healthcare environment • Minimum 3 years of people management or supervisory experience • Demonstrated experience with Health Canada requirements, GMP compliance, drug importation and Drug Establishment Licences • Experience conducting vendor audits and hosting or co-hosting client, third-party or regulatory audits is considered an asset • Experience working as a consultant is considered an asset • Experience with natural health products is considered an asset • Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidance • Strong working knowledge of DEL requirements, importation controls, GMP documentation, risk assessment and quality systems • Proven ability to manage, motivate and develop employees; set clear expectations; provide practical training; delegate effectively; and foster accountability, collaboration and respectful professional relationships • Skilled in deviations, root cause analysis, CAPA and risk assessment • Strong written, verbal, presentation, and public-speaking skills • Advanced proficiency in Microsoft Word and Excel • Ability to quickly learn and adapt to new technologies and enterprise systems • Works effectively independently and in cross-functional, multidisciplinary teams • May involve travel up to 20%

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities