The Manager of Quality Assurance Training is responsible for ensuring that quality training programs are developed, implemented and effectively administered consistently, in a manner that maximizes efficiency, complies with industry standards, and achieves desired compliance targets. Lead the development and implementation of GxP training and continuing education programs throughout bluebird. Partner with functions to identify GxP training and educational needs, articulate goals for meeting these needs, and identify creative, high impact and sustainable approaches for meeting these goals. Work closely with the Learning and Development team to align on common processes. Provide leadership and management of the training program to ensure that the appropriate training activities are developed and implemented in line with strategic objectives.
About the position:
- Develop, manage and communicate bluebird bio’s GxP training requirements and initiatives.
- Serve as Administrator of bluebird bio’s Learning Management System (LMS).
- Provide technical expertise and innovative ideas to continuously improve upon quality training programs and advance training effectiveness.
- Oversee training logistics, delivery, metrics and maintenance.
- Providing timely and metric driven updates on the status of training programs
- Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with company goals and corporate training philosophy.
- Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
- Provide training instruction and deliver courses
- Bachelors’ and/or Masters’ degree in scientific discipline.
- A minimum of 5 years of training experience in the industry is required.
- Technical understanding of biopharmaceutical production and knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements is necessary
- Strong influencing, partnering and collaboration capabilities arerequired
- Ability to work in matrixed environment and with key stakeholders to drive high quality decisions
- Excellent facilitation, presentation, instructor skills
- Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
- Ability to travel on occasion
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
- Project management experience.
- Experience with regulatory inspections and audits.
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
- ComplianceWire/ELMS experience preferred.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.