Associate Director, QA – Batch Release
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking an Associate Director, QA – Batch Release responsible for Quality Assurance leadership and oversight for GMP manufacturing operations to assure compliance with U.S. and international regulatory requirements, including development, implementation, maintenance, and performance of quality assurance systems and programs at Ajinomoto Althea. This position is responsible for the management of batch record and disposition activities across the Company.
- Management of Batch Review and Disposition Activities
- Oversees QA review and disposition activities for intermediary, bulk and finished product batch records.
- Evaluates the impact of critical and major deviations and adverse events to product quality and facilitate detailed product impact analysis in collaboration with subject matter experts including client collaboration.
- Performs detailed analysis of manufacturing processes; identifies sources of variance and determines corrective and preventive actions to resolve complex issues.
- Provides detailed performance metrics to peers and senior management at regular intervals.
- Ensures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events during batch production.
- Oversight and Support of GMP Manufacturing Activities
- Provides direct QA oversight of the GMP facilities including Manufacturing, Quality Control, Raw Materials, Facilities and Batch Release functions.
- Manages the site sterility assurance program
- Collaborates in the technical development, review, and approval of GMP manufacturing production batch records (MBR/MPR) and standard operating procedures (SOP).
- Monitors and ensures QA oversight of manufacturing floor activities during GMP production.
- Acts as the primary QA point of contact for clients when deviations arise on the production floor.
- Leads complex deviation investigations, mobilizes cross functional teams including subject matter experts to collaborate on complex issues and create innovative solutions.
- Facilitates the investigation of critical and major deviations, excursions and other quality events occurring during manufacturing activities. Provides leadership to facilitate efficient closure of quality events.
- Key liaison between company and clients regarding Quality and Regulatory issues; communicates directly with client’s senior Quality and/or Regulatory staff.
- Hosts/Co-Hosts regulatory audits, including audit preparation, execution of the audit, the audit report, and follow up to any findings. Serves as a liaison between the Company and auditors.
- Lead Development of appropriate corrective and preventive actions to prevent re-occurrence of quality events. Provide oversight of the implementation of corrective and preventive actions (CAPA).
- Innovation and Continuous Improvement
- Leads continuous improvement and operational excellence programs.
- Develops and improves KPIs, metrics, and management review reporting.
- Continually evaluates quality systems supporting GMP manufacturing operations for potential improvements.
- Implements new and existing procedures to new manufacturing sites; Authors and revises SOP, protocols and work instructions as required.
- Generates and implements policies and procedures in support of the clinical and commercial manufacturing facility.
- Generates and evaluates trend reports and metrics to measure key quality attributes in manufacturing operations.
- Implements corrective and preventive actions to address adverse trends and quality systems gaps.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.
- Bachelor’s degree in a Life Sciences discipline or equivalent.
- Generally requires eight to ten (8-10) years of relevant experience in a regulated biotech, or pharmaceutical industry.
- Seven (7) years in a quality supervisory position performing Quality Assurance functions including batch release.
- Working knowledge of cGMPs, FDA regulations, ICH Guidelines for Manufacture of APIs, and familiarity with the European Community Guidelines for GMP.
- Working knowledge of drug development and strong knowledge of operations in an aseptic processing facility required.
- Experience with restricted access barrier system (RABS) and isolator technology is highly desirable.
- Strong written and verbal communication skills are required.
- Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member.
- Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
- Must be familiar with Microsoft Office applications.
- Directs and provides expert knowledge in the day-to-day function of the Quality Assurance group.
- Identifies, recruits, and retains top-notch talent.
- Champions Althea’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.
- Provides oversight and direction to the employees in accordance with Althea’s policies and procedures.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.