Validation Manager

6 months ago

Hamilton, 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 on-going 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 risk-based 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 on-site 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 fast-paced, growth-oriented 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 high-quality work even under pressure.
- Strong client-facing and teamwork skills.

**AtomVie offers**
- Group Health & Dental Benefits (starts from Day 1)
- RRSP Matching
- Parking Allowance
- Training & Career Development
- Opportunity for long-term growth
- Collaborative environment with experienced individuals in the field
- Join a passionate team making a difference in patients’ lives

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