Job Description

Req #1603Monday, August 12, 2024BIOVECTRA 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.At Biovectra, we are passionate about improving patient care by making better therapeutics as a contract drug manufacturing organization (CDMO) that supports the top pharmaceutical and biotech companies in the world. Be part of a team with a global reach that also has a great community vibe. We care about each other and live our values of teamwork, respect, professionalism, and quality. Diversity is one of our strengths as we strive to offer a welcoming and inclusive environment.We have an opening for Quality Assurance Validation Manager. This is a permanent position based out of either our Windsor, Nova Scotia or Charlottetown, PEI facilities.About the role:The Quality Assurance Validation Manager will direct quality oversight to a multi-disciplinary team and 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 manage policies and activities related to environmental monitoring, equipment qualification and process validation including review and approval, risk assessment, incident investigation, and corrective/preventative action plans.In this role, you will be responsible for:

• Managerial oversight of the Quality Validation teams across all sites.
• Demonstrating the ability to understand complex quality issues and drive scientifically sound and compliant resolutions.
• Ensuring continuous improvement, harmonizing quality systems and teams, and strengthening quality awareness.
• Providing managerial and quality support for validation and qualification application across systems (equipment and instrument qualification, basis of design, design and controls assessment, computer systems, policy etc.) to ensure facility and site compliance, including risk assessments and investigations.
• Implementing the Environmental Monitoring program across BIOVECTRA sites to ensure cleanroom, water, and other utilities comply with regulations.
• Multi-disciplinary project management such as schedule preparation, planning, directing, and managing designated projects and major change control initiatives including team training on documentation and procedure.
• Reviewing existing systems for gaps related to validation and proposing/implementing strategies to mitigate the risks.
• People Leadership: providing guidance and oversight to direct or indirect reports. Responsible for Human Resources services for your direct or indirect reports; including pay, attendance management, and employee performance management.
• Participating in external audits and leading internal audits.
• Leading and/or assessing and approving major and critical investigations; including strategizing, planning, and managing investigative team.
• Participation in the budgetary process for the Quality Unit.

About you:

• Bachelor degree in a scientific, engineering or pharmaceutical manufacturing field.

• Validation Certification would be an asset.
• Five years\xe2\x80\x99 work experience in a manufacturing environment, pharmaceutical experience is an asset.
• Hands on experience with supporting or leading validation and qualification in accordance with regulations (ICH, 21 CFR Part 210 and 211, EMA, ISPE, Annex 15), environmental monitoring programs (EU Annex 1 and 2, ISO Cleanrooms), and computer system validation (GAMP5, ISPE, 21 CFR Part 11) is required.
• Experience in project oversight with a strong business acumen.
• A leader who can take initiative and make decisions. This is a fast-paced team, and priorities can often change and compete with one another.
• Can travel between our Charlottetown and Windsor locations.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the \xe2\x80\x9cApply Now\xe2\x80\x9d button below.Closing Date: August 23, 2024Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply! We thank all interested parties; however, only those applicants considered for an interview will be contacted.

BioVectra