Senior Specialist, Quality Systems

Resilience•West Chester, OH

49d•$80,000 - $117,500

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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

Benefits

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.

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