Validation Manager

7 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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
The Quality Assurance Manager (Validation) oversees compliance with Good Manufacturing Practices (GMP) in relation to validation and qualification activities.

These activities are performed in support of the production of both clinical and commercial products, from the introduction of new programs to the routine manufacturing phase at AtomVie facilities.


The Quality Assurance Manager (Validation) is a focused and motivated individual responsible for managing a team of QA professionals performing validation, qualification, and other associated quality compliance activities.


What You Will Do

  • Through ongoing monitoring and review, ensures compliance with GMP requirements, company's policies, and procedures.
  • Works collaboratively with stakeholders to ensure AtomVie systems are kept current to new regulatory trends and industry standards.
  • Oversees validation and qualification activities.
  • Manages a team of direct reports to achieve efficient results and adhere to standard compliance.
  • Accomplishes QA human resource objectives by training, assigning, scheduling, coaching, communicating job expectations, mentoring, monitoring, assessing performance, supporting career development activities, and enforcing policies and procedures.
  • Oversees validation and qualification requirements and projects ensuring timely and accurate execution.
  • Ensures a riskbased methodology is applied to GxP validation and qualification activities as per company's guidelines.
  • Reviews, assesses, and approves protocols, reports, specifications, scripts, risk assessments, change controls, CAPAs and investigations, etc. as required.
  • Supports and participates as SME in onsite audits by regulatory authorities and clients ensuring audit readiness.
  • Acts as a designate for the Quality Assurance Director (when/where required).
  • Provides expertise and advice as it relates to validation and qualification activities.
  • Oversees validation and qualification projects to ensure successful completion.
  • Identifies and drives opportunities for improvement to AtomVie's quality management system.
  • Meets on a regular basis with the Quality Assurance Senior Director / Director to provide updates on ongoing activities, track and set priorities, and address issues and problems.
  • Works closely with other departmental managers to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs.
  • Communicates quality and compliance issues to all relevant stakeholders in a timely manner.
  • Ensures AtomVie is inspection ready and is operating within a compliant quality environment.
  • Ensures compliance with Health and Safety, engaging all associates to comply with the policies, procedures, and regulations applicable to their job.
  • Completes all other duties as assigned.

Experience Necessary

Education/Certifications

  • BSc or equivalent in Pharmacy, Engineering, Chemistry, Microbiology, or a related field.

Experience/Skills

  • 5 to 10 years of qualification and validation experience in the pharmaceutical, radiopharmaceutical or biopharmaceutical industry.
  • Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products id preferred.
  • 5 years of demonstrated leadership and behavioural competencies.
  • Exposure to computer systems validation preferably in the pharmaceutical industry in the areas of Quality, IT, and Manufacturing.
  • Knowledgeable in GxP, GDP, GAMP, 21CFR Part 11, and industry best practices.
  • Attention to detail, highly organized, critical thinking, strong problem solving, interpersonal and verbal skills.

Other

  • Adaptable with a desire for working in a fastpaced, growthoriented environment.
  • Ability to work with a sense of urgency, prioritize work, meet objective/deadlines with strong organizational skills.
  • Strong project management skills with the ability to work independently and within a team.
  • Able to drive improvement projects and deliver highquality work even under pressure.
  • Strong clientfacing and teamwork skills.

AtomVie offers

  • Group Health & Dental Benefits (starts from Day 1)
  • RRSP Matching
  • Parking Allowance
  • Training & Career Development
  • Opportunity for longterm growth
  • Collaborative environment with experienced individuals in the field
  • Join a passionate team making a difference in patients' lives

  • Validation Officer

    6 days ago

    Hamilton, Ontario, Canada Scotiabank Full time

    Requisition ID: 161333Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.PurposeValidation Officer contributes to the overall success of the Dealer Finance Centre (DFC) in Canada ensuring specific individual goals, plans, initiatives are executed / delivered in support of the team's business strategies and...

  • Senior Validation Lead

    6 days ago

    Hamilton, Ontario, Canada Fusion Pharmaceuticals Full time

    Fusion Pharmaceuticals (NASDAQ:FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.Fusion's clinical portfolio includes: FPI-2265 targeting...

  • Senior Validation Lead

    2 weeks ago

    Hamilton, Ontario, Ontario, Canada Fusion Pharmaceuticals Full time

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting...

  • Manager, Cash Management

    7 days ago

    Hamilton, Ontario, Canada CIBC Full time

    We're building a relationship-oriented bank for the modern world. We need talented, passionate professionals who are dedicated to doing what's right for our clients.At CIBC, we embrace your strengths and your ambitions, so you are empowered at work. Our team members have what they need to make a meaningful impact and are truly valued for who they are and...

  • Project Manager

    7 days ago

    Hamilton, Ontario, Canada First Onsite Full time

    _We don't do what we do because we're heroes. We do it because we're human-and because we're all in this together. We're not a corporate machine, we're a team of real people out to do some real good-and that's our superpower. Be real. Be genuine. Be yourself._ We've got humanpower and that's what makes our difference. __Do you feel this passion for people...

  • Branch Manager

    7 days ago

    Hamilton, Ontario, Canada Brinks Full time

    About the jobWe currently have an exciting opportunity for a Branch Manager based from our Hamilton, Ontario facility. Reporting directly to the Regional Manager, the incumbent will be responsible for the day-to-day operations at our Hamilton facility. As Branch Manager, you will provide leadership and direction for all logistics, scheduling, service...

  • Manager in Training

    6 days ago

    Hamilton, Ontario, Canada Healthy Planet Full time

    Manager In TrainingResponsibilities Ensure that the store is operating optimally and report to Operations Manager in Head Office should an issue arise Freezers and coolers Cleanliness of the departments HVAC Plumbing ADT Security and Security Cameras Pest Control Maintain adequate inventory and stock based on monthly sales Organize products based on expiry...

  • Asset Management Program Planner

    7 days ago

    Hamilton, Ontario, Canada City of New York Full time

    IMPORTANT NOTE:Only those currently serving as a permanent or probable permanent Associate Project Manager will be considered.The NYC Department of Environmental Protection (DEP) protects public health and the environment by supplying clean drinking water, collecting and treating wastewater, and reducing air, noise, and hazardous materials pollution. DEP is...

  • Community Services Manager

    6 days ago

    Hamilton, Ontario, Canada Thrive Group Full time

    We are currently hiring 1 Community Services Manager to join our Community Services Teams in the Hamilton and Burlington area. AbleLiving Services and Capability Support Services are a part of the Thrive Group. We are a not-for-profit organization that provides services funded through Ontario Health.Interested in bringing your talent to our team? Here is...

  • Branch Manager

    6 days ago

    Hamilton, Ontario, Canada Roofmart Full time

    Fantastic Opportunity to Be Part of a Great TeamRoofmart, Canada's National distributor for Exterior Building Supply for Roofing, Siding, Metal and Building Envelope. With over 50 Roofmart locations across Canada, we are strategically positioned to handle all our customer needs. We are looking for Enthusiastic, Driven, Outside of the Box Thinkers to help us...

  • general manager

    6 days ago

    Hamilton, Ontario, Canada Data-line Accounting Solutions Inc. Full time

    general manager - financial, communications and other business services Verified Salary 90.00 hourly / 30 to 40 hours per week Terms of employment Permanent employment Full time Start date Starts as soon as possible Verified Source Job Bank # Education Experience 3 years to less than 5 years Business services Responsibilities Tasks Allocate...

  • General Sales Manager

    6 days ago

    Hamilton, Ontario, Canada AutoCanada Inc. Full time

    General Sales Manager (GSM)Subaru of HamiltonHamilton, ONSubaru of Hamilton is in pursuit of the next level in automotive excellence and, as the industry evolves & our story continues to transform, we are looking for an experienced full time General Sales Manager to join us in writing our next chapter You will lead/execute our new/used vehicle sales...

  • managing supervisor

    7 days ago

    Hamilton, Ontario, Canada Petra Tires Full time

    Education: Secondary (high) school graduation certificateExperience: 5 years or more or equivalent experienceWork settingRetail service establishmentRetail businessRetail/wholesale establishment/distribution centreTasksDirect and control daily operations Plan and organize daily operationsManage staff and assign dutiesStudy market research and trends to...

  • Project Manager

    7 days ago

    Hamilton, Ontario, Canada Palcon Excavating Full time

    Responsibilities: Assist the General Manager in planning, documentation, implementation, and overall management of projects. Review contract documentation in detail and understand all aspects of the work. Plan upcoming work (manpower, equipment, materials). Evaluate and compare subcontractor bids, scope of work, and issue POs to the winning subs. Negotiate...

  • Assistant Manager

    6 days ago

    Hamilton, Ontario, Canada McMaster University Full time

    ScheduleMay include weekendsEducation LevelCollege Diploma in Food & Beverage Management or equivalent.Career LevelMinimum 2 years in Junior Management or Supervisory capacity in Hotel, Club or Catering CompanyJOB PURPOSE: Under the direction of the Senior Manager or Catering Manager, the Assistant Manager assists in the day-to-day task supervision of...

  • Account Manager

    6 days ago

    Hamilton, Ontario, Canada American Iron and Metal Full time

    Company DescriptionAmerican Iron & Metal (AIM) is a family-owned company and recognized global leader in the metal recycling industry with more than 125 sites and 3500 employees worldwide. We have continued to prosper for the last eight decades (we just celebrated our 86th birthday) thanks to the dedication of our employees and the ongoing trust and support...

  • Assistant Warehouse Manager

    7 days ago

    Hamilton, Ontario, Canada Driven Brands Full time

    Description : Specific responsibilities include: •Under direction of the Site Manager, provides training and oversight to site employees and provides general operational guidance; serves as role model to other team members •Ensures policies, practices and procedures are understood and followed by team members and customers •Performs warehouse...

  • Key Accounts Manager

    6 days ago

    Hamilton, Ontario, Canada Collective Arts Brewing Full time

    Are you a strategic thinker with a passion for building key relationships? Are you results oriented and have a passion for driving sales and exceeding targets? If so,the Key Accounts Manager at Collective Arts is right for you. Collective Arts is a dynamic Canadian beverage company dedicated to blending the creativity of our beverages with the inspired...

  • Store Manager

    6 days ago

    Hamilton, Ontario, Canada Sherwin-Williams Full time

    The Store Manager is responsible for overseeing the daily operations of their store, making sure it runs smoothly and effectively. This includes managing all aspects of store operations, including scheduling, customer service, marketing, merchandising, inventory, financial reporting, and safety. You will also manage, develop, and motivate store employees as...

  • General Sales Manager

    7 days ago

    Hamilton, Ontario, Canada AutoCanada Inc. Full time

    General Sales ManagerRightRide HamiltonHamilton, OntarioRightRide Hamilton is in pursuit of the next level in automotive excellence and, as the industry evolves & our story continues to transform, we are looking for an experienced full-timeGeneral Sales Manager to join us in writing our next chapter You will lead/execute our new/used vehicle sales strategy,...