Job Description
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.
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Position Summary
This position resides in the Quality Systems & Compliance Team and provides strategic and tactical leadership to GMP compliance programs & processes, quality systems, and computerized systems. The incumbent will:
* Manage and execute required quality and GMP compliance activities to ensure compliance with GMPs and regulatory filling, providing inspection readiness of the site and maintaining the license to operate
* Be the lead/process owner of one or more quality systems across the site, including oversight responsibilities of the quality system's process, procedures, monitoring, and maintenance. The incumbent will demonstrate proficiency in the Quality System of ownership
* Drive continuous improvement efforts through monitoring of site systems and processes against current compliance requirements and influencing key stakeholders on recommended compliance improvements
Quality Systems & Compliance Site Support
Quality oversight of assigned West Chester's Business Execution Teams (BETs) such as Labs, Engineering, Warehouse, MSAT, etc., including approval of related GMP documentation
Act as a process owner of one or more quality systems (i.e., Deviation Management, Change Control, 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
Support the periodic revision of the APQRs & Site Master File
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 the 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
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 $80,000.00 - $110,000.00 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.
RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans
