Senior Quality Assurance Validation Associate

at  BioVectra Inc

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.
We have an opening for a Senior Quality Assurance Validation Associate. This is a permanent, full-time position located in Windsor, NS.
The Senior Quality Assurance Validation Associate will manage policy and application of validation and qualification activities across all BIOVECTRA manufacturing locations, inclusive of equipment, computer systems, and process, and in accordance with current industry standard and good manufacturing practices (GMP). This position will require interacting with multiple departments and external stakeholders (including clients and consultants) and is responsible for contributing to the leadership of the QS Validation Team and managing direct reports.

In this role, you will be responsible for:

• Providing guidance and oversight to the QS Validation team including timesheets, vacation, employee performance review feedback and evaluation, and ensuring employees comply with GMP and safety training and requirements.
• Overseeing validation and qualification program requirements across systems (equipment qualification, basis of design, design and controls assessment, computer systems, risk reviews, etc.) to ensure facility and site compliance.
• Managing the daily validation program requirements at all sites, including scheduling, and assigning tasks to the QA Validation Associates.
• Providing validation guidance, advice and support to management, project teams and external stakeholders (including clients and consultants).
• Determining, tracking, and assessing key performance indicators for the QS Validation team and implementing continuous improvement measurements based on results.
• Demonstrating the ability to understand complex quality issues and drive scientifically sound compliant resolutions.
• Multi-disciplinary project management such as schedule preparation, planning, directing, presenting, and managing designated projects including team training on documentation and procedures.
• Leading quality investigations. This includes working with cross functional teams to identify root causes, developing corrective actions, creating investigation summary reports and presenting findings to stakeholders.
• Participation in the budgetary process for the Quality Unit.
• Contributing to the leadership of the Quality Unit as a member of the Quality Systems Leadership Team.
• Reviewing existing systems for gaps related to validation, developing solutions and propose / implementing strategies to mitigate the risks.
• Participating in external audits and leading internal audits.
• Researching, developing and implementing program policy improvements for the validation programs.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.

As the successful candidate for this position, you have:

• Bachelor degree in a scientific, engineering or pharmaceutical manufacturing field.
• Five years’ experience with a food or drug manufacturing company, preferable in a Quality Unit position.
• Three years’ validation and qualification experience.
• Previous leadership experience is an asset.
• Certified Quality Engineer is an asset.
• Travel between NS and PE is required.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply

• Providing guidance and oversight to the QS Validation team including timesheets, vacation, employee performance review feedback and evaluation, and ensuring employees comply with GMP and safety training and requirements.
• Overseeing validation and qualification program requirements across systems (equipment qualification, basis of design, design and controls assessment, computer systems, risk reviews, etc.) to ensure facility and site compliance.
• Managing the daily validation program requirements at all sites, including scheduling, and assigning tasks to the QA Validation Associates.
• Providing validation guidance, advice and support to management, project teams and external stakeholders (including clients and consultants).
• Determining, tracking, and assessing key performance indicators for the QS Validation team and implementing continuous improvement measurements based on results.
• Demonstrating the ability to understand complex quality issues and drive scientifically sound compliant resolutions.
• Multi-disciplinary project management such as schedule preparation, planning, directing, presenting, and managing designated projects including team training on documentation and procedures.
• Leading quality investigations. This includes working with cross functional teams to identify root causes, developing corrective actions, creating investigation summary reports and presenting findings to stakeholders.
• Participation in the budgetary process for the Quality Unit.
• Contributing to the leadership of the Quality Unit as a member of the Quality Systems Leadership Team.
• Reviewing existing systems for gaps related to validation, developing solutions and propose / implementing strategies to mitigate the risks.
• Participating in external audits and leading internal audits.
• Researching, developing and implementing program policy improvements for the validation programs.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company