Change Control Manager

Grifols

. Develop, manage and oversee a global risk-based audit program for Grifols Canadian Plasma GMP activities .

Posted 10/26/2026full-timeWinnipeg • CanadaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing and managing global risk-based audit programs, ensuring compliance with GMP and regulatory standards. Proficient in conducting quality audits and training personnel within the pharmaceutical industry.

Highest-signal resume keywords

GMP Auditing ExperienceAuditor CertificationQuality Management CertificationRegulatory Compliance KnowledgeSupplier Qualification Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP Requirements KnowledgeQuality Audit DevelopmentData InterpretationRisk AssessmentAudit Program Implementation

Soft Skills

Excellent Communication SkillsOrganizational SkillsAnalytical MindsetTime ManagementEffective Presentation Skills

Tools & Technologies

Microsoft Office

Certifications & Qualifications

Bachelor's Degree in Health-related SciencesPost-Graduate Certification in Quality ManagementAuditor Certification

Industry Keywords

Pharmaceutical IndustryCGMPFDA StandardsEuropean StandardsQuality Agreements

About the role

Key responsibilities & impact

Develop, manage and oversee a global risk-based audit program for Grifols Canadian Plasma GMP activities
Participate in risk-based GMP internal and external audits
Lead auditing and supplier qualification personnel training and development programs
Oversee and provide feedback to Quality Audit specialists and report risks and actions to senior management
Provide quality direction on regulatory updates affecting the GMP audit program
Develop and implement systems and processes supporting global audit and quality assurance requirements
Support regulatory inspections, notified body audits, and other external audits
Establish an internal audit program for compliance with Canadian regulations, cGMP requirements, FDA and European standards
Assess supplier change notifications with related departments
Maintain and supervise Quality Agreements with critical suppliers
Manage new and renewal site certifications, including operational license, GMP and IQPP

Requirements

What you’ll need

Bachelor's Degree in Health-related Sciences, preferably in Pharmacy
Post-Graduate Certification in Quality Management
Proven experience in GMP auditing within a Pharmaceutical Company is preferred
Knowledge of GMP requirements preferred
Auditor certification
Minimum of 10 years of general experience
6 years performing quality audits in a GMP environment within the pharmaceutical industry
Proficiency with computers using Microsoft Office
Organized and able to manage time effectively
Ability to work within a highly regulated, labor-intensive environment
Analytical and enquiring mind with the ability to interpret data and facts
Excellent oral and written communication skills to produce clear and concise factual findings and the ability to present effectively to groups
Effective organizational and planning skills with the ability to meet deadlines required