Position Description
The Senior Corporate Quality Auditor will perform the following activities :
- In collaboration with the Senior Manager, Corporate Quality and Compliance Excellence and internal stakeholders, execute the national corporate audit strategy.
- Assist the Sr. Manager, Corporate Quality and Compliance Excellence in assessing the current state of the site quality system process documentation and partner with key business units to strive for continuous improvement / best practices.
- Assist the Sr. Manager, Corporate Quality and Compliance Excellence in developing a formal reporting system to communicate and track results of audit activities and trends to management such as dashboards and other metrics.
- Ensure compliance activities milestones are met.
- Audit the Quality systems and associated processes for integrity of GxP documents and determine discrepancies.
- Ensure that audit issues are well documented and root causes are identified and addressed.
- Collect information on remediation efforts, track progress and communicate milestones and deliverables to Senior. Manager, Corporate Quality and Compliance Excellence and relevant stakeholders.
Section A Specific Responsibilities
- In collaboration with the Senior Manager, Corporate Quality and Compliance Excellence, will develop site self-inspection program, and participate in the execution of the program.
- Prepare and execute the corporate periodic self-inspections plan.
- Follow-up on responses highlighting potential risks.
- Review corrective actions implementation timeliness.
- Support external and internal audit as required.
- Use reporting system to communicate results of audit activities and trends to management through dashboards and other metrics.
- Prepare the corporate vendor audit plan and conduct assigned vendors audits.
- Oversight of the vendors qualification program across the Quality business units.
- Conduct periodic risk assessment activities as required.
- Assist with requests from various system owners, businesses, internal and external audit teams.
- Ensure that an action plan is put in place to address any issues discovered during audits.
- Manage compliance projects as required.
- Participate in the development, writing and revision of SOPs, WIs, policies and corporate training materials as required.
- Participate in the preparation of the quarterly quality executive meetings with the business and collect the KCIs.
- Demonstrate commitment to ILEAD and ICARE principles and encourage others to do the same.
Section B Position Requirements
- Bachelor’s degree in science or related field.
- Minimum of 7 years of experience in pharmaceutical industry including auditing role.
- Auditor certification considered an asset.
- Excellent knowledge of cGMP, Controlled Substances regulations, precursors regulations, and Medical Device regulations in pharmaceutical environment.
- Knowledge of Good Pharmacovigilance Practice and pharmacovigilance regulations considered an asset.
- Up to 50% travel will be required to other McKesson Canada locations or vendors offices and facilities.
Additional Skills :
- Strong analytical and problem-solving skills.
- Ability to work independently and make decisions based on judgment and integrity.
- Good written and oral communication skills in both English and French.
- Ability to handle multiple assignments in a fast-paced environment.
- Facts and data driven with attention to details to ensure consistency.
- Strong interpersonal skills.
- Ability to collaborate with various levels of management and teams.
- Ability to lead continuous improvement activities through involvement and engagement of others.
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets.
The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.
In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
For more information regarding benefits at McKesson, please
Our Base Pay Range for this position
$86,600 - $144,300
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