Associate Director, Quality Assurance - GMP Ops

Company: Althea Ajinomoto Inc
Location: San Diego
Posted on: March 20, 2023

Job Description:

Why join Ajinomoto Bio-Pharma?
Our mission is to help improve the health of humankind.
We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.
We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.
Total Rewards package designed to make your life better:
We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!
Your next career move: We are currently seeking an Associate Director of Quality Assurance that will lead quality operational support activities for our aseptic fill finish facilities including new HPP and ADC production capabilities. This is a leadership role with focus on the start-up and execution of GMP operations for all production areas, ensuring QA oversight and support for manufacturing operations, batch disposition, QC, and Validation activities. This includes client interfacing support and collaboration. The Associate Director is a key member of cross-functional site leadership, and reports to the Director or Sr. Director of Quality Assurance.
Responsibilities:
- Leads all aspects of quality assurance at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
- Manages key quality assurance metrics/site goals, supports critical program milestones, and drives continuous improvement initiatives that are essential to meeting client and business needs.
- Establishes and improves Quality Systems and processes.
- Implements industry best practices and current GMPs to meet regulatory and customer requirements.
- Collaborates with internal departments to ensure effective regulatory and customer feedback responses/corrective actions are generated in a timely manner.
- Oversees the processes for QA on the Floor (OTF) support, Visual Inspection AQLs, and Batch review/disposition.
- Manages QA support for impact assessments and review of change controls, deviation investigations, and CAPAs.
- Assists in regulatory inspections including scheduling and task prioritization (US FDA, EMA, & PMDA).
- Independently investigates, troubleshoots, and rectifies issues resulting from QA analysis.
- Champions operational excellence (OE) projects for QA Compliance and continuous improvement.
- Rapidly and accurately communicates issues to Senior Leadership.
- Maintains awareness of recent developments in industry, clients, competitors, and regulatory agencies.
- Ensures that safety standards are maintained.
- 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 strategic function of Quality Assurance.
- Develops short and long-term people and organizational strategy in alignment with Aji Bio-Pharma goals and direction.
- Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.
- Identifies, recruits, and retains top-notch talent.
- Champions Aji Bio-Pharma's culture and empowers employees to take responsibility for their jobs and goals.
- 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.
Requirements :
- Bachelor's degree in a Life Sciences discipline or equivalent experience required.
-Minimum of 10 years of relevant experience in Quality Assurance or a bachelor's degree with 8 years of minimum experience.
- Minimum of 4 years of functional leadership experience.
- Knowledge of global cGMP regulations and good documentation practices.
- Experience interacting with clients, regulators and senior staff.
- Experience with electronic Quality Systems preferred.
- Experience with various phases of commercial drug development (clinical Phase I - III through commercial approvals) preferred.
- Deep understanding of aseptic processes, equipment, automation, validation, cleanrooms, and other classified area requirements.
- Working knowledge of industry practices, global regulations and experience interacting with multiple health authorities (e.g. FDA, EMA, PMDA, etc.).
- Effective cross functional collaborator (Manufacturing, Facilities, Supply Chain, Project Management, etc.) and efficient at removing barriers.
- Mindset and proven ability to drive inspection readiness at all times.
The anticipated salary range for candidates who will work in California is $129,426.85 to $181,197.60.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states. 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.
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Keywords: Althea Ajinomoto Inc, San Diego , Associate Director, Quality Assurance - GMP Ops, Executive , San Diego, California