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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 & Responsibilities

The Senior Specialist II, Quality Compliance is responsible for providing both tactical and strategic leadership for compliance management processes and Quality Management Systems (QMS) activities at the site. The core responsibilities of the role are as follows:

• Manage critical compliance processes and QMS and lead/execute required activities to ensure the site meets current GMP requirements of all local/global regulations and internal Resilience Quality and Compliance policies
• Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current Compliance and QMS requirements and influence key stakeholders on recommended Compliance and QMS improvements
• Act as the functional leader/process owner of more than one of the site QMS and/or Compliance processes including but not limited to: Management Review/Quality Council, Quality Metrics, Operational Excellence/Continuous Improvement, QA-QA Client Management, Quality Agreements, Escalation Management, etc.
• Lead meetings maintaining agenda, minutes, active communication, actions tracker, and track metrics.
• Serve as the site point of contact (SPOC) for the applicable QMS and 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 QMS and/or 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.
• 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.
• Collaborate with other Resilience sites and Global teams to create standard quality systems requirements and compliance processes where possible. Work in partnership with the Global Process Owner (where applicable) to ensure compliance with global policies

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: aseptic and sterile product manufacturing processes, inspection, packaging, labelling, testing, etc.
• Excellent investigational and QA problem solving skills.
• Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams.
• Strong leadership, project management, and technical writing
• Strong interpersonal, communication, and influencing skills.
• Experience in tracking and trending meaningful metrics for assigned activities.

Preferred Qualifications

• Bachelor’s degree in a science/technical field such as pharmacy, biology, chemistry, or engineering
• Extensive experience in QA/Regulatory Compliance in the pharmaceutical industry
• Prior experience managing Quality Systems and compliance processes.
• ASQ certifications (e.g., CQA, CQE, and CQM)

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 $95,000.00 - $132,500.00 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.