Senior Specialist II, Quality Compliance

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 Senior Specialist II, Quality Compliance is responsible for providing both tactical and strategic leadership for quality compliance management processes and quality client management activities at the site.

Position Responsibilities:

Quality Compliance Management

• This role is the functional leader/process owner of more than one of the site compliance processes including but not limited to: Management Review/Quality Council, QA-QA Client Management, Quality Agreements, Escalation Management, Self-Inspections, etc.

  • Lead meetings maintaining agenda, minutes, active communication, and actions tracker.

  • Serve as the site point of contact (SPOC) for the applicable QA compliance process with site teams, global teams, and clients.

  • Develop, implement, and maintain SOPs, quality oversight plans, tools, and other supporting documents for the applicable quality compliance process.

  • Partner with team leads on identified quality issues, quality/compliance trends, and works within the team to address and mitigate identified risks.

• Escalate and inform timely leadership and clients on the evaluation and management of site specific escalations, as applicable.

• Provide reports on quality trends, observations, and suggestions to leadership and clients, as applicable.

• Maintain current knowledge of regulatory and industry trends, and actively communicate those to the site including but not limited to 21CFR210, 21CFR211, 21CFR600s, 21CFR820, ISO 13485, Annex 1, etc.

Client Management

• Client Assessment: Understand quality client requirements, expectations, and feedback to ensure the company can effectively meet the quality agreement requirements. Identify areas for improvement for the overall client partnership.

• Issue Resolution: Proactively identify and resolve client concerns related to quality and compliance, coordinate with internal teams to find appropriate solutions. 

• Progress Reporting: Provide regular updates to clients on the progress of deviations, change controls, validations, and other quality documentation. 

• Communication Management: Serve as the quality primary point of contact for client inquiries, resolve issues, and ensure clear and consistent communication between clients and relevant internal teams related to quality and compliance.

Leadership

• Build and maintain effective internal Resilience business relationships within operational and support units.

• Promote and encourage continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognizing and rewarding high performance.

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

• Lead/drive improvements to quality compliance processes through cross functional project teams.

• Collaborate and influence key operations customers and stakeholders at all levels of the organization: globally and inside and outside of QA to deliver significant improvements in quality compliance to drive site improvements.

• Coach and empower site colleagues to successfully execute quality systems and compliance processes.

Inspection Readiness

• Participate in internal audits and external quality system inspections conducted by the FDA and other regulatory agency representatives including client quality audits.

• Provide active support to the Logistics Center or Inspection Room during an external audit/inspection.

Minimum Qualifications:

• Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines

• Knowledge of pharmaceutical and biotechnology processes, such as: aseptic and sterile product manufacturing processes, inspection, packaging, labelling, testing, etc.

• Excellent investigational and QA problem solving skills<