Senior Quality Assurance Consultant in Pharmaceutical and Medical Device Industries

Description The Senior Quality Assurance Consultant will lead critical initiatives in quality assurance and regulatory compliance within the pharmaceutical and medical device sectors. This role involves partnering with key stakeholders to create remediation plans and leading various projects, including Cell Therapy Manufacturing Data Integrity Remediation and Medical Device Remediation. You will assess and initiate a quality approach for system implementations, guide validation processes, and mentor internal quality engineers. Company Culture and Environment The work environment emphasizes collaboration, mentorship, and a commitment to quality and compliance. There is a focus on developing internal talent and fostering strong relationships among teams and stakeholders. Career Growth and Development Opportunities The position includes mentoring opportunities for internal quality engineers and IT staff, providing avenues for professional development and career advancement within the organization. Detailed Benefits and Perks

• Flexible working arrangements supporting remote work
• Opportunities to work with diverse teams across multiple geographic areas
• Involvement in various projects across different time zones, enhancing exposure to international practices

Compensation and Benefits

• Competitive salary commensurate with experience
• Comprehensive health benefits
• Retirement savings plan
• Paid time off policies and flexible work hours

Why you should apply for this position today This role presents a unique opportunity to make a significant impact in the pharmaceutical and medical device sectors while working with innovative technologies and methodologies. If you are passionate about quality assurance and regulatory compliance, this is the chance to advance your career and contribute to meaningful projects. Skills

• Extensive experience in quality assurance and regulatory compliance
• Expertise in cell therapy manufacturing and cloud-based data management systems
• Strong networking and communication skills between technical teams and regulatory bodies
• Excellent mentorship and coaching abilities
• Strong understanding of GMP, GLP, GxP, and relevant regulatory standards
• Experience with Lean and Agile Software Development Lifecycle Procedure
• Proficient with Jira and familiarity with audit processes
• Fluent in German

Responsibilities

• Partner with stakeholders to create remediation plans for quality issues
• Lead the transition to structured, risk-based remediation projects
• Assess and implement quality approaches for system implementations
• Validate and qualify systems based on project needs
• Guide risk-based validation considering audit findings and patient safety
• Identify and track recurring issues using data analysis
• Mentor and develop internal quality engineers and IT staff
• Engage in mock audits and assist with actual audits and inspections

Qualifications

• Proven experience in quality assurance within pharmaceutical and medical device sectors
• Strong background in cell therapy and data management systems
• Demonstrated ability to mediate between technical teams and regulatory bodies
• Excellent mentorship and coaching skill set
• Familiarity with regulatory standards and compliance practices

Education Requirements

• Bachelor’s degree in a relevant field; advanced degree preferred

Education Requirements Credential Category

• Related fields such as Life Sciences, Engineering, or Quality Assurance

Experience Requirements

• Extensive experience in quality assurance roles with a focus on regulatory compliance
• Demonstrated experience leading quality initiatives and mentoring teams
• Familiarity with working across multiple time zones and international teams

Why work in Cambridge, MA Cambridge is a hub of innovation and education, home to numerous prestigious institutions and a thriving tech scene. The city offers a vibrant cultural landscape, with access to diverse culinary experiences, parks, and recreational activities. Living in Cambridge provides a stimulating environment that fosters both personal and professional growth. Apply tot his job Apply To this Job