Manager, Change Management Program

Location
San Diego, CA
Posted
Nov 02, 2020
Required Education
Bachelors Degree
Position Type
Full time

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 Change Management to join our Quality Assurance team. This position leads Ajinomoto Bio-Pharma’s change management program and performs a wide variety of activities supporting quality management system (QMS) documentation as well as Facility and Engineering changes, all while ensuring compliance with applicable regulatory requirements.

 

Responsibilities :

  • Reviews and develops QMS change control practices and policies, including Facilities & Engineering required changes. 
  • Continually assesses the efficiency and effectiveness of Ajinomoto Bio-Pharma’s change management program.
  • Leads program improvement initiatives and collaborates closely with stakeholders to implement solutions.
  • Hosts change review board meetings and leads feasibility assessments and other deliverables.
  • Manages and performs in-depth analysis of complex QMS documentation change requests including SOP’s, master batch records, methods, material specifications, protocols, and reports as well as GMP facilities, utilities and equipment management processes.
  • Develops, monitors and presents KPIs to senior leadership, evaluating program effectiveness and identifying improvement opportunities.
  • Leads and actively participates in Quality system documentation and Engineering related product and process impact assessment efforts, and supports investigations as part of change management program.
  • Oversees facilities and equipment computerized maintenance management system (CMMS) identification and tracking as well as QA support of the validation and metrology program.
  • Performs QA compliance review of batch records, validation reports and protocols.
  • Creates, revises, and reviews SOPs. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
  • Manages logbook documentation audits for cGMP regulated logs and SOPs.
  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

 

Leadership Responsibilities:

  • Directs and provides expert knowledge in the day-to-day functions of Technical Quality and Document Control.
  • 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, engages and develop the team and its leaders, 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.
  • Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.

 

Requirements :

  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Minimum of 7 years of experience in QMS Change management process, Facility and Engineering or equivalent.
  • Minimum of 3 years of leadership/supervisory experience.
  • Strong knowledge and hands-on experience with GLP, cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and GDP.
  • Previous experience within aseptic processing operations supporting calibration programs, maintenance failure investigations, impact & risk assessments, and environmental process control requirements strongly preferred.
  • Demonstrated ability to utilize and/or implement process and system improvement methodologies and tools.
  • Detail oriented, with strong written and verbal communication skills.
  • QMS database experience required; experience with Master Control, Trackwise, or ACE preferred.
  • Must be familiar with Microsoft Office applications and data analysis tools and techniques.

 

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
  • 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

 

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.