Biomanufacturing Quality Assurance Director
7 days ago
A career at Resilience offers a unique opportunity to make a lasting impact in the field of biomanufacturing.
The company is pioneering a revolutionary approach to medicine production, and as a key member of their team, you will play a crucial role in ensuring the highest standards of quality and compliance.
This position may also include the following conditions: Pre-employment medical exams will be performed, and regular re-examinations may be required every 2 years or as per RESILIENCE's SOPs.
Job flexibility may be necessary to support operations, with possible variations in work schedules.
About UsWe are Resilience Biotechnologies Inc., a leading innovator in biomanufacturing technology. Our mission is to transform the way medicine is produced, making it more sustainable, efficient, and accessible to those in need.
About This RoleThis role requires a strong background in supervisory management and technical expertise in analytical methods and validation.
You will be responsible for managing the overall site Quality Control laboratories to deliver accurate and timely testing results.
Key responsibilities include:
- Developing and maintaining a high-skilled team of analysts and personnel to support optimal service delivery and maintain high levels of compliance and inspection readiness
- Implementing controls for data integrity, documentation, sample management, reagent and reference standard management, instrument and equipment management controls
- Partnering with Digital Quality to ensure implementation of requisite controls to assure data integrity
- Managing deviations, LIRs, and OOSs, including CAPA Effectiveness Checks
- Reviewing and mentoring personnel involved in investigations for critical and major deviation reports
To be successful in this role, you will require:
- SIGNIFICANT experience in a Supervisory/Managerial role in Quality Control
- Technical background understanding of analytical methods and method validation, including technology transfers
- Demonstrated analytical and problem-solving skills
- In-depth knowledge of GxP Regulations and guidance, particularly data integrity and various compendia (USP, EP, JP)
- Detail-focused and strong attention to detail and accuracy
- Strong presentation skills
Candidates with a University Master's degree in Science with a major in Life Sciences, Biochemistry, Chemistry or Pharmacology and significant experience in GxP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or Ph.D degree with significant in GxP positions are preferred.
BenefitsWe offer a comprehensive total rewards program that includes equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.
Our target base pay hiring range for this position is $145,000 - $205,000 per year. Actual base pay is dependent upon a number of factors, including but not limited to, relevant experience, qualifications, skills, and knowledge.
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