Together, Let’s Make A Difference.
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.
Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.
Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.
We are currently seeking a Manager of QA Compliance to join the team and lead audit inspection readiness for Aji Bio-Pharma’s clinical and commercial manufacturing facilities. This role oversees quality management system (QMS) activities such as risk assessments, audit follow-ups, and client contractual agreements to ensure compliance with U.S. and international regulatory requirements.
- Manages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs.
- Develops technical acumen and decision-making skills in direct reports.
- Oversees Aji Bio-Pharma’s risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders.
- Leads complex audit, deviation and CAPA investigations.
- In collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality.
- Manages quality event trend reports and metrics to measure key quality attributes.
- Accountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations.
- Develops and maintains relevant quality sections of contractual agreements with clients.
- Directs and provides expert knowledge in the day-to-day function of QA Compliance.
- Identifies, recruits, and retains top-notch talent.
- Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
- Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
- Bachelor’s degree in a Life Sciences or Engineering discipline, or equivalent.
- Minimum of 7 years of relevant QA experience in a regulated industry: Biotech or Pharmaceutical industries strongly preferred.
- Minimum of 3 years of leadership or supervisory experience.
- Experience with aseptic processing; experience with restricted access barrier systems (RABS) and isolators preferred.
- Working knowledge of cGMPs, FDA regulations, ICH Guidelines in drug/device, and familiarity with the European Community guidelines for cGMPs.
- Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
- Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
- Experience with process mapping, data analysis and presentation software such as Visio, Microsoft office, Excel, PowerPoint, etc.
We provide a Total Rewards package designed to make life better – both at work and at home.
- Annual Bonus Opportunities for All Employees
- 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
- Paid Parental Leave
- Annual Company Shutdown in December
- Comprehensive Medical, Dental + Vision
- 401K Company Match + Immediate Vesting
- Backup Daycare and Eldercare
- Monthly Employee Appreciation Events and Food Truck Fridays
- Employee Discount Programs
- Tuition Reimbursement
- Casual Dress Code
- Wellness Programs
- Community Outreach Opportunities
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the “Careers” section. Please be sure to note where you saw our ad posting.
New hires will pass a background check and drug screen as a condition of employment.
We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.