Associate Director of Quality Assurance

General Description

The Associate Director of Quality Assurance manages quality and compliance-related responsibilities for Andelyn Quality Assurance and Andelyn-sponsored manufacturing activities concerning relevant Standard Operating Procedures, applicable Regulatory requirements, and current industry standards and practices. Oversees the development, implementation, and maintenance of both Corporate and GMP/GLP quality assurance systems and activities. Responsible for all validation activities, investigations, and CAPAs across the Company.

Principal Duties and Responsibilities

Leads and directs the implementation of QA policies and procedures to ensure cohesive and consistent quality plans are executed (includes Quality systems, cGMP/GLP, and other regulatory standards as applicable).
Develops and implement the overall quality strategy for the facility.
Partners with the other Heads of Departments and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
Acts as the lead SME for significant quality/compliance issues within the asset
Manages the asset QA budget and resources to maximize efficiency and maintain quality/compliance at high levels.
Interfaces with site QA functions for equipment, facility, cleaning, and computer validation/qualification and the site-based QA systems.
Oversees all aspects of QA operations within the facility, including but not limited to batch record review, on-the-floor QA support, deviation investigations, change controls, Quality agreements, and SOP and master batch record review.
Responsible for the release of clinical and commercial batches.
Ensures QA support for internal and external projects and team meetings.
For significant issues, interfaces with customers and internal groups for the resolution of quality issues.
Has decision-making authority for all asset Quality issues; informs Site QA Head of critical issues in a timely manner.
Builds and maintains expertise in the asset QA team, ensuring the development of staff.
Applies quality/manufacturing experience, including process validation, to ensure that operations meet customer and regulatory expectations
Prior experience in biologics API or drug product Quality Assurance is required; experience in mammalian cell-derived biologics is desired, but not essential.
A strong foundation in the application of GMP in a drug substance or drug product manufacturing environment is critical.
Strong knowledge in the application of cGMP requirements to biologics manufacturing processes, and the purpose and function of supporting processes.
Understanding of facility design requirements and operating principles for biologics manufacturing.
Understanding of validation/qualification principles, industry practices, and standards with the ability to apply these to GMP operations as a QA leader.
Working knowledge of all Quality Systems required for a biologics manufacturing facility.
Exercise discretion, judgment, and personal responsibility.
Demonstrate a high level of integrity.
Maintain a positive attitude.
Attention to detail in all job functions.
Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed.
Develop strategic planning and guidance for their functional unit in alignment with the overall organization and influence organizational strategic planning on an executive level.
Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization. Also is involved in organizational objectives on an executive level.
Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of organizational goals.
Ultimate oversight on the development and enforcement of procedures and controls.
Establish a strategic process to control work procedures.
Complete budgetary control over the functions under their control also influences the organizational budget establishment.
Frequent travel required.
Responsible for hiring, development, and related personnel processes.
Mentoring and professional development of staff.
Make use of essential people skills, including the ability to develop subordinates.
Ability to manage and influence people in a direct and lateral support structure.
Ultimate decision-making latitude within their functional units and influences decisions on an organizational level.
Drives timelines and development through broad influence.
Ultimate interaction with legal services.
Develop and direct short and near-term goals.
Responsible for developing a 3–5-year business plan.
Responsible for Revenue (P&L).
Interprets Regulations for application within their functional unit
Has business acumen and considers business impacts in planning and problem solving.
Responsible for business development.
Other duties as assigned.

Knowledge, Skills, and Abilities Required

Must possess a relevant four-year degree OR relevant Master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
Broad knowledge of the field with proven leadership skills.
Prior management experience is required.
Second-level manager. Manages the activities of first-level managers and/or supervisors.
Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
Must possess a client-focused mindset in daily tasks.
Must possess prior experience handling confidential information and the ability to maintain confidentiality.

Minimum Physical Requirements

· Frequently sitting/remaining in a seated position

· Occasionally standing or walking

· Occasionally independently lifting to 50 pounds

· Frequently talking on the phone or in-person

· Frequently keyboarding

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual copied, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.