A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position SummaryThe Senior Associate, Quality Operations, completes the quality activities to support manufacturing operations in accordance with Resilience policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing batch production records and supporting documentation (logbooks, work orders, etc.), and working directly with manufacturing and cross-functional teams to complete area and process walkthroughs. This role will be located at the RTP site, reporting to the Sr. Manager of Quality Operations, and requires all activities to be performed onsite. Approximately 50% of job responsibilities will require a presence in manufacturing production areas to support active batch processing and perform real-time review of documentation.
Job Responsibilities

• Review manufacturing batch production records and supporting documentation (logbooks, alarm reports, work orders, disruptions to the controlled environment, etc.).
• Actively monitor manufacturing activities within the production suites to support potential quality/compliance events, provide guidance on documentation comments, and ensure compliance with applicable procedures.
• Perform area and process walkthroughs within manufacturing, warehouse, and utility areas.
• Review and approve operational SOPs, Master Batch Records, and logbook templates.
• Review and approve minor deviations and CAPAs as assigned.
• Build and maintain relationships with Manufacturing Operations, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements, and resolve issues.
• Ensure compliance with applicable procedures and production requirements. Perform follow-up on potential non-compliances and escalate to management as necessary

For all activities described above:

• Critically review each task, ask questions, interpret information and results, and generate conclusions consistent with Quality risk management principles.
• Provide direct feedback to individuals performing work and Supervisors regarding observations made during review and steps required to remediate such as comments to correct documentation and decision whether a deviation is required.

Work Schedule:

• 4 days/week (Monday, Tuesday, Thursday, Friday) from 7:00 am-5:30 pm with the ability to adjust as needed to support the manufacturing production schedule and team priorities
• -OR- 5 days/week (Monday-Friday) from 7:00 am-3:30 pm with the ability to adjust as needed to support the manufacturing production schedule and team priorities
• Requires occasional on-call and on-site support for off-shift manufacturing activities.

Minimum Qualifications

• Quality and compliance mindset
• Knowledge of cGMP manufacturing processes for biologics, vaccines, or cell/gene therapy products
• Batch record review experience
• Must be proficient in Quality Systems, particularly Deviation and CAPA
• Experience using electronic Quality Management Systems (eQMS)
• Ability to communicate requirements to stakeholders and escalate obstacles to management
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Must be skilled in planning and organizing, making decisions, and building relationships
• Knowledge of quality processes including material storage and handling requirements, aseptic practices, Good Documentation Practices (GDP)

Preferred Qualifications

• Bachelor’s degree or higher in Life Sciences discipline or 8 years of experience in a GMP-regulated environment plus responsibilities for review of documentation may be substituted in lieu of a degree
• Minimum of 3 years of pharmaceutical or biopharmaceutical industry experience
• Continuous improvement mindset
• Ability to lead cross-functional teams
• Experience with delivering presentations, facilitating, and teaching to diverse audiences
• Desire and interest to leverage new technology and innovative learning techniques
• Excellent interpersonal, verbal, and written communication skills
• Experience with supporting regulatory inspections
• Extensive knowledge of manufacturing and testing processes for biologics, vaccines, cell/gene therapy products
• Data and metric-driven
• Strong attention to detail

The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $112,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.