-
Supervisor, Regulatory Compliance
1 week ago
Halton District School Board Burlington, Canada**Position**: Supervisor, Regulatory Compliance · **Salary Range**: Band 7 - $ 79,206 - $ 94,456 · **Location**: JWS Guelph Line, Burlington, Ontario · **Work Schedule**: 35 hours/week · **Effective Date**: As Soon As Possible · **Position Summary**: · The Supervisor, Regulatory ...
-
Regulatory Compliance Associate
23 hours ago
BZAM Management Inc Jerseyville, CanadaBZAM Ltd. is as awesome as it sounds · The Regulatory Compliance Associate shall assist in maintaining the facility Regulatory program and participate in activities to meet production process and regulatory standards, working in an office and facility environment from our Ancaste ...
-
Regulatory Compliance Specialist
1 week ago
Sigan Industries Group Brampton, Canada**Position: Regulatory Specialist (Healthcare and Beauty)** · The Regulatory Compliance Specialist will be responsible for preparing regulatory documents and submissions, as well as reviewing consumer product labels. · This role will involve collaborating closely with the Senior ...
-
Regulatory Compliance Manager
23 hours ago
Dexterra Group Mississauga, CanadaCompany Description · **WHO ARE WE?** · We've been serving Canadian clients for over 75 years. The companies that began independently and now form Dexterra Group have an outstanding record of supporting the infrastructure and built assets that play a vital role in our society and ...
-
Regulatory Compliance Manager
1 week ago
Dexterra Group Mississauga, CanadaCompany Description · **WHO ARE WE?** · We've been serving Canadian clients for over 75 years. The companies that began independently and now form Dexterra Group have an outstanding record of supporting the infrastructure and built assets that play a vital role in our society and ...
-
Regulatory Compliance Coordinator
1 week ago
Reochem Inc. Milton, CanadaThe Regulatory Compliance Coordinator will be responsible for preparing regulatory documents and submissions, as well as reviewing consumer product labels. This role will involve collaborating closely with the Director of Regulatory Affairs to ensure all regulatory requirements a ...
-
Regulatory Compliance Officer
5 days ago
KeAnu Inc. Milton, CanadaEducation: Bachelor's degree · - Experience: 2 years to less than 3 years · **Work setting**: · - Consulting firm · **Tasks**: · - Analyze and provide advice on the managerial methods and organization of an establishment · - Conduct research to determine efficiency and effectiven ...
-
Food Regulatory and Compliance Specialist
5 days ago
King's Pastry Inc. Mississauga, Canada**About King's Pastry** · King's Pastry is a leading commercial bakery in Canada, founded in 1996. With our passion for desserts, infinite perseverance, high adaptability, and the spirit of innovation we have become a trusted and reputable dessert manufacture. Our products are fe ...
-
Manager Gmp Regulatory Compliance
2 hours ago
Thermo Fisher Scientific Mississauga, CanadaAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide ou ...
-
Regulatory Compliance Manager
4 days ago
Delmar International Mississauga, Canada Full timeMandate: · Reporting to the Vice President of North American Customs Services, the Regulatory Compliance Manager will be responsible for providing the full range of Canadian customs regulatory and advisory services to support our clients as well as the internal staff. · Other R ...
-
Regulatory Compliance Manager
4 days ago
Delmar International Inc. Mississauga, Canada Full timeMandate: · Reporting to the Vice President of North American Customs Services, the Regulatory Compliance Manager will be responsible for providing the full range of Canadian customs regulatory and advisory services to support our clients as well as the internal staff. · Other R ...
-
Regulatory Compliance Associate Analyst
1 week ago
Primerica Mississauga, ON, CanadaAbout this Position We are looking for a Compliance Analyst to join our Compliance department. Researching and analyzing applicable legislative and regulatory actions concerning segregated fund and insurance products, ancillary products, field operations and home office administr ...
-
Analyst, Regulatory Compliance Management
1 week ago
DynaCare Inc Brampton, ON, Canada Full timeJob Posting: End User & Lab Technologies Analyst · Dynacare is helping Canadians achieve a healthy future with care and wellness solutions that are convenient, understandable, and accessible. It's an environment where you can grow your career in any direction you choose. We're e ...
-
Vice President Quality
2 hours ago
Centre For Probe Development And Commercialization Hamilton, CanadaAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. · **About ...
-
Regulatory and Customer Affairs Coordinator
1 week ago
Flair Airlines Ltd. Hamilton, Canada**Want to be part of a team that's changing the way Canada travels?** · As Canada's largest independent ultra-low-cost airline, that's exactly what we're doing at Flair Airlines. By consistently offering airfares that are a fraction of the ticket prices of "those other airlines", ...
-
Quality Assurance Associate
3 days ago
AtomVie Global Radiopharma Inc. Hamilton, CanadaAtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. · **About the Role** · Reporting ...
-
Quality Assurance Associate
5 days ago
Centre For Probe Development And Commercialization Hamilton, CanadaAtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. · **About the Role** · - Reportin ...
-
Regional Health and Safety Coordinator
1 week ago
Environmental 360 Solutions Hamilton, Canada**Company Overview** · Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming North America's leading and most trusted environmental management company. Growing through acquisition and organic growth, E360S provides environmental and waste management soluti ...
-
Regional Health
1 week ago
Environmental 360 Solutions Hamilton, Canada**Company Overview** · Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming North America's leading and most trusted environmental management company. Growing through acquisition and organic growth, E360S provides environmental and waste management soluti ...
-
Credit Analyst
23 hours ago
Scotiabank Hamilton, CanadaRequisition ID: 168632 · Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. · **Purpose** · Contributes to the overall success of the Lending Services department of Scotia Dealer Advantage in Canada ensuring specific individual ...
Vice President, Quality Assurance and Regulatory Compliance - Hamilton, ON, Canada - Allergan
Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people's lives.
As a quality organization in research & development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product's lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie's evolved business strategy are complex, rapid pace, and dynamic.
Emphasizing and embedding quality in the execution of clinical trials, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.
An elevated, focused, and evolved Good Clinical Practices (GCP) strategy and pipeline partnership are essential.The Vice President Clinical Quality Assurance is a key role in R&D, responsible for leading the Clinical Quality Assurance function and partnering with AbbVie's R&D Clinical Development organization to achieve consistent high-quality clinical research outcomes.
The VP Clinical Quality Assurance provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs).
The role collaborates with R&D clinical development senior leaders and stakeholders to develop, implement, and continuously improve global and local GCP quality strategies that align with AbbVie R&D pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
This role reports directly to the Vice President of R&D Quality Assurance and is a member of the R&D Quality Leadership Team.
There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.
Develop, implement, and ensure continuous improvement of the clinical quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices.
Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
Drive effective and efficient execution of clinical quality assurance projects/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and continuous improvement efforts.
Pioneer industry leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across GCP activities.Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
Consult and partner with the R&D Quality Internal Audit team to ensure appropriate focus areas of clinical operations, including investigator sites, vendors, and internal processes.
Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external/internal requirements including seamless integration with R&D and Executive Management review.
Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and auditors.Drive a culture of continuous improvement in clinical quality assurance.
Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance.
Evolve, develop, lead, guide, and mentor a growing geographical dispersed clinical quality assurance team, responsible for the execution and sustainability of GCP across the R&D clinical trial/study portfolio.
Set clear expectations, manage performance, and foster a positive collaborative working environment for a geographically diverse team located around the world.
Bachelor's degree required, preferably in Biology, Chemistry, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience.~15+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, quality systems, or a combination of those or comparable experiences. Tactical and strategic clinical quality assurance experience required. Quality assurance, quality systems, and/or quality compliance background experience are highly desirable.
~ Thorough understanding of global and local clinical trial/study regulatory requirements and processes in multiple disciplines (Pharma and Medical Device). Must be able to make critical, creative, and strategic decisions as a result of rapid analysis of available information. This must include thorough risk-assessment for the integrity of the product, patient rights/safety, and for the business. Thus, a balance must be maintained between quality and productivity
~10+ years leadership experience and exemplary tactics in motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive information and situations.
~ Ability to manage difficult conversations and seek alignment. Strategic, creative, and "big picture" thinker, considered a visionary. Demonstrated executive presence. Ability to direct and coach all aspects of work projects (strategic and tactical) effectively within evolving and at times rapidly changing priorities and deadlines.
~ Evaluates performance, ability to differentiate various performance levels, and assists in career development planning for employees within responsibility.
Additional Information AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#
