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QA Audit Manager
Sentrex Health Solutions
- Markham, Ontario, Canada
- Markham, Ontario, Canada
About
Department: QA General and Admin
Work Location: Markham, Ontario
Work Arrangement: Hybrid/Remote
Work Hours: Monday to Friday - standard business hours
Travel Required: 5-10% throughout Canada
A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in-house creative agency, and experienced, cross-functional teams. Our core capabilities include Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services as well as HCP & Clinic Services.
Come and join our team But first, let us tell you why we love working here:
We are 100% Canadian with locations across the country
State-of-the-art facilities to provide high-quality products and services
The opportunity to be a part of a winning, high-performing team
Collaborative, engaging workplace culture – we are passionate about our people
Flexible working environment that promotes a healthy work-life balance
Diverse and inclusive culture where your talent and commitment to excellence is welcomed and valued
High-growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry-leading, in-house corporate training offered throughout the year
The Opportunity:
The QA Audit Manager role is based in our facility in Markham, Ontario and the key functions include working with cross-functional teams to ensure the Quality Management System (QMS), Risk Management, internal controls, Business Continuity Plan, and individual Disaster Recovery Plans are current and being followed. In addition, verification through audits and self-inspections that they are supported internally and by our vendors/sub-contractors. In this role you will schedule, conduct and document assigned audits (both internal and external) as well as cohosting client regulatory inspections in compliance with approved procedures and schedules.
The QA Audit Manager is responsible for planning, executing, and overseeing internal audit activities with a primary focus on evaluating and strengthening Sentrex's internal control environment. You will also be an ambassador for the Quality Culture at Sentrex.
A Day in the Life (What you will do here):
The QA Audit Manager will contribute to the team's success by:
Maintaining the approved vendor list, vendor audit schedule and self-inspection schedule. Strategically making audit recommendations to senior Quality Management.
Performing risk ranking on suppliers based on products or services provided, on-site audit history and vendor deviation trends.
Performing annual Risk Assessments of Sentrex's operations, reviewing mitigating actions on an annual basis.
Supporting the organization's risk management activities by verifying business continuity and disaster recovery plans are thorough, inclusive and successfully tested.
Scheduling and performing audits of vendors and internal self-inspections (e.g. Patient Support Program, Warehouse GMP, external vendors, etc.) as per the audit schedule.
Generating and communicating supplier key performance indicators (KPIs).
Developing Audit related PowerPoint Presentations for internal stakeholders.
Coordinating and managing supplier deviations and CAPA reports.
Writing and communicating audit reports, close-out letters in accordance with company formats and timelines ensuring clear communication of audit findings to the relevant project team members.
Reviewing CAPAs for audit observations from vendors and internal stakeholders and providing guidance on applicable regulations.
Following up with suppliers and internal stakeholders to ensure timely closure of audit observations.
Writing and reviewing applicable Standard Operating Procedures (SOPs).
Participating in and / or co-hosting client and regulatory audits.
Maintaining accurate and timely documentation of QA auditing activities.
Assisting with maintaining current Quality Agreements.
Assisting with developing and mentoring the Quality Assurance team in line with the strategic direction identified by senior Quality Management.
Additional Quality Assurance duties as determined by your Manager.
Some travel within Canada may be required.
What you need to ensure you are set up for success:
You have a Bachelor of Science degree in Chemistry, Biochemistry, Biology or other related discipline and a minimum of five (5) to seven (7) years of knowledge and working experience with all aspects of GMP quality assurance which relate to a pharmaceutical organization.
You are well organized and detail oriented.
You have a thorough knowledge and understanding of Canadian (Health Canada) Food and Drug Regulations and guidelines.
You have experience with GMP, GVP, GCP, ICH regulations, and guidelines.
Experience with risk management (e.g., ICH), business continuity and/or disaster recovery is an asset.
Experience with GMP auditing software vendors and/or GAMP V / CSV is an asset.
Experience auditing PSP – Patient Support Programs is an asset.
Experience with ZenQMS or other QMS auditing software is an asset.
You have excellent English verbal and written communication skills.
Bilingualism (French/English) is considered an asset.
Experience participating in regulatory agency inspections is an asset.
Certification in a recognized quality auditor program is an asset (e.g., CQA).
What makes you a great fit for this team:
Your commitment to providing a high level of service to your internal and external clients.
You are highly adaptable with a track record of success during times of growth and organizational change.
You have a proven track record of developing trust and influence at multiple levels.
You demonstrate an impactful and candid communication style.
You have exceptional organizational skills with the ability to build effective working relationships with colleagues, management, and stakeholders.
Why join Sentrex?
We value our employees Our permanent full-time employees are provided with a:
Competitive Salary and generous vacation entitlement
Wellness Program (5 paid days off for your well-being)
Paid Sick Days
Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance
Employee & Family Assistance Program
RRSP Matching Program
The anticipated base salary hiring range for this role is 105K to 110K annually. The final base salary will be determined based on relevant experience, skills, and internal equity.
Sentrex Health Solutions is proud to be an equal opportunity employer demonstrated by our commitment to diversity, inclusion, belonging, equity, and accessibility. We provide a safe space for all team members to express their individuality within our corporate culture.
We encourage you to apply and accept all applications. We realize that not every candidate will meet every single desired qualification. If your experience looks a little different from what we have identified and you think you can bring value to the role, we would love to learn more about you
Accommodations can be made available upon request for those candidates taking part in the selection process.
Sentrex hiring managers may use artificial intelligence tools to assist them in the recruitment process.
Languages
- English
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