Senior/Lead Associate, QA Operations

About the role

Be an integral part of the Quality Assurance and Quality Systems team by providing advanced quality oversight and technical expertise to operations, manufacturing, and quality control activities. Ensure product quality and compliance with applicable regulations and Genezen quality policies and procedures. Serve as a subject matter expert and day-to-day leader for a team of Quality Operations Associates by providing technical guidance, coaching, training, work prioritization, and performance support while fostering a culture of quality, collaboration, and continuous improvement.

Responsibilities

• Serve as the technical lead for Quality Operations Associates, providing coaching and guidance on GMP compliance, quality systems, investigations, and documentation.
• Prioritize daily QA floor support activities to ensure appropriate coverage across manufacturing operations.
• Review work performed by junior associates for accuracy, completeness, and compliance prior to final approval, where applicable.
• Mentor team members in deviation investigations, CAPAs, change controls, and root cause analysis.
• Lead continuous improvement initiatives that enhance quality systems, operational efficiency, and inspection readiness.
• Partner with Quality leadership to identify training needs and competency development for the team.
• Assist management with resource planning, scheduling, workload balancing, and escalation of quality issues.
• Serve as a primary QA representative for cross-functional projects and strategic initiatives.
• Lead complex investigations, high-impact deviations, and quality risk assessments.
• Act as the QA Operations delegate for management during periods of absence as assigned.
• Provide Quality oversight for Manufacturing, Quality Control, and related operations to ensure compliance with GMPs, SOPs, and regulatory requirements.
• Guide production personnel on GMP compliance, SOP adherence, and process improvements.
• Review batch records, logbooks, and cleanroom documentation for accuracy, completeness, and compliance.
• Ensure quality documentation complies with cGMP, GDP, and Genezen quality standards.
• Develop, review, approve, and maintain SOPs and other controlled Quality documents.
• Review, approve, and release raw materials, quality control results, and Certificates of Analysis.
• Review and approve executed batch records and provide guidance to reduce documentation errors.
• Support final disposition activities for master cell banks and viral vector products.
• Deliver GMP and GDP training for new hires and existing employees, as needed.
• Lead investigations of Quality Events, including deviations and environmental excursions, using root cause analysis and cross-functional collaboration.
• Drive Quality Events to timely and effective closure in accordance with established deadlines.
• Review and approve specifications for labels for media fills, master cell banks, and viral vector products.
• Review and approve Media Fill and Stability protocols and reports; serve as a Quality observer as needed.
• Initiate, review, approve, and monitor CAPAs and Change Controls to ensure timely implementation and effectiveness.
• Provide guidance to cross-functional teams on Quality Systems and GMP compliance.
• Support internal audits, customer audits, and regulatory inspections.
• Collaborate with Operations, Manufacturing, QC, Regulatory, and QA teams to ensure compliance with approved procedures and regulatory requirements.

Requirements

• Adaptability required as work schedule may change based on business needs.
• Criminal background check and drug screen required.

Qualifications

• Bachelor’s degree in science or related field.
• 6 - 8+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role.
• Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials.
• Previous experience providing technical leadership, mentoring, or supervisory responsibilities.
• Experience working with early phase clinical trial production and testing.
• Previous experience with a startup CDMO and/or in the field of Gene Therapy.
• Familiarity of eQMS systems such as Veeva.
• Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms.
• Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms.

Skills

• Manage multiple projects, set priorities, and work in fast-paced, ever-changing environment.
• Communicate confidently and effectively with management, peers, and key stakeholders.
• Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving.
• Work independently and be self-motivated.
• Proven ability to work cross-functionally to achieve business outcomes.

Physical Demands

• Occasionally exposed to loud noise levels.
• Regularly sit for long periods of time.
• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• Frequently utilize close vision and the ability to adjust focus (20/20 or Corrected 20/20 Vision).
• Frequently required to communicate by talking, hearing, using telephone and e-mail.

Company Values

• Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.
• Solutions driven for our partners: We are committed to being a proactive, collaborative, creative, and open-minded partner.

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays + 2 floating holiday + 1 volunteer day.
• 401(k) plan with company match up to 6% of salary.
• Share Appreciation Rights.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Dental & vision care.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.
• Accidental Death & Dismemberment (AD&D) Insurance.

Locations

Genezen operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. It was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety, and entrepreneurship. Fishers is one of the fastest-growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community, and the world’s largest children’s museum.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.