Senior Specialist, Quality Systems

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 Summary

The Sr. Specialist, Quality Systems, provides both strategic and hands-on leadership for GMP compliance programs, quality systems, and computerized systems. The incumbent will oversee and execute key quality and GMP activities to ensure inspection readiness and site compliance, while serving as the lead or process owner for one or more quality systems. They will also drive continuous improvement by monitoring site processes and influencing stakeholders on recommended compliance enhancements.

Job Responsibilities

Quality Systems & Compliance Site Support

Act as a process owner of one or more quality systems (i.e., Deviation Management, Change Control, Quality Risk Management, Supplier / Client Complaints, etc.) across the site

Manage QA to QA interactions with clients, including, but not limited to, quality event notifications and periodic meetings

Assist in the maintenance and implementation of the Quality Systems

Collaborate and influence other functions and teams to drive the continuous improvements activities and corrective and preventive actions

Contribute to the training, education, guidance, and influencing of operational and support areas on quality and compliance policy and practices

Develop and implement quality improvement programs and processes, and ensure management and employee quality responsibilities are met

Review and approval of data and documentation created during quality activities to ensure consistency with company policies, procedures, and specifications

Keep management team advised of significant issues or department trends during quality system reviews

Prepare and present technical and quality system program information to management

Assist in generating metrics for overall quality systems and identify continuous improvement opportunities

Maintain a working knowledge of applicable regulatory requirements to ensure departmental compliance

Formulate and maintain quality system objectives complementary to corporate policies and goals

Focus on building effective working relationships throughout the organization to achieve business goals

Collaborate with other Resilience sites and central functions to create standard quality systems requirements where possible. Work in partnership with the global process owner (where applicable) to ensure compliance with global policies

Lead projects or actively participate on project teams related to compliance, quality systems, and continuous improvement initiatives across PETs, sites support groups, and cross-site groups

Participate in quality risk assessment activities, where applicable

Cross-train to provide back-up support for other roles under Compliance and Quality Systems

Support site new product launch lifecycle by providing cGxP compliance guidance

Manage / support the periodic revision and execution of the APQRs, Site Master File & Mock recall

Manage / update ERP master data, where applicable

Inspection Readiness

Support the preparation, planning, logistics, and execution of the self-inspections, mock inspections, and any other inspection readiness activities

Actively support the Logistics Center and / or Inspection Room during an external audit / inspection

Support the Internal Audit (Self-Inspections) Program and drive corrective actions to completion

Provide Quality Systems and Compliance's routine reports as required for support of regulatory documents, inspections, or focus teams

Ensure compliance with regulatory filings and the documentation system at the site

Minimum Qualifications

Considerable experience in pharmaceutical industry and QA

Knowledge of pharmaceutical compliance, industry best practices, and a strong familiarity with production operations

Knowledge of regulatory / cGMP requirements

Excellent oral and written communication skills

Strong ability and motivation to learn

Good decision-making skills and judgment skills

Ability to coach and mentor peers

Preferred Qualifications

Bachelor's degree in a science / technical field such as pharmacy, biology, chemistry, or engineering

Prior experience in quality assurance / regulatory compliance in the pharmaceutical industry

Prior experience with regulatory inspections

ASQ certifications (i.e., CQA or CQE)

Member of pharmaceutical trade associations, such as ISPE or PDA

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 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 $80,000.00 - $117,500.00 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.