Responsibilities:

• Ensure the implementation and maintenance of Quality Systems, including the compliance status of change controls, non-conformances, CAPAs, and SCARs internally and with suppliers 
• Provides GMP advice at all levels of the company, including support to the development of processes and procedures that are compliant with international QMS requirements and product development/design controls 
• Interacts with suppliers including performing audits as part of the supplier management process 
• Manage Inspection Readiness activities for Quality Systems 
• Support the overall process to Identify/develop, measure and monitor metrics which are key performance indicators and provides these metrics reports to senior management 
• Disposition commercial and clinical lots through batch documentation review
• Manages Quality Associate responsible for document management 
• Oversees administration of the documentation and training management system and ongoing improvements 

Required Expertise Competencies:

• BS degree or postgraduate qualification in nursing, life sciences or medical sciences, or equivalent work experience 
• Minimum of seven years of experience in Quality Assurance in the pharmaceutical/combination product industry, including a minimum of two years’ experience with electronic documentation systems; Master Control experience a plus 
• Experience in developing quality systems in a growing company

Required Power Competencies:

• Teamwork & Leadership: Functional influencer; builds effective partnerships and works collaboratively with others to meet shared objectives; knowledge of company structure; deliberately includes and inspires colleagues and team members.
• Execution: Consistently directs, drives, and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work
• Solution Maker: Dissects functional work/process issues to discover opportunities for improvement; leverages resources to deliver function-level solutions/improvements; begins building internal and external networks; demonstrates courage to ask questions, try new things, and provide feedback
• Continuous Improvement: Creates new ways for self and team to be effective; proactively leverages resources where appropriate; early adopter and implementer of technology and student of industry.
• Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions
• You excel at working both individually and in a team environment 
• You are passionate about your work and display a high level of emotional intelligence in your decision making 
• You understand, appreciate, and thrive in a growing organization and have the desire to learn new skills to contribute to company success
• You can manage various projects, solve problems, and deliver on commitments 
• You can understand strategy, transition to execution, and effectively collaborate cross functionally 
• You have excellent communication and collaborative skills 
• You strive for excellence and expect the same from your team and colleagues 

Expectations:

• This position is hybrid with a minimum of two days per week in our Burlington, MA office, between Tuesday and Thursday. Additional time in the office could be required as circumstances dictate.
• Ability to travel up to 10% of the time