Technical Quality Lead

Company: Resilience
Location: Boston
Posted on: September 4, 2024

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.For more information, please visit Position SummaryThe Technical Quality Lead is accountable for central quality oversight of Validation Programs, including Computer System Validation (CSV), Facilities, Utilities, and Equipment (FUE), Analytical Equipment Qualification (AEQ), Cleaning Validation (CV), and Process Validation (PV). This role is accountable for the development, implementation, and lifecycle management of the Data Integrity program and related processes.Job Responsibilities

• Provides central quality oversight of Validation Programs, including Computer System Validation (CSV), Facilities, Utilities, and Equipment (FUE), Analytical Equipment Qualification (AEQ), Cleaning Validation (CV) and Process Validation (PV).
• Acts as a QA representative/SME/approver for central Validation documents and records.
• Provide support to Deviations, CAPAs, and Change Control for applicable systems.
• Provides global quality oversight to Digital Systems implementation projects and associated artifacts across the Resilience network, ensuring a robust and compliant Data Integrity program across the network.
• Owns the Data Integrity Program.
• Act as an owner of Data Integrity Standards
• Oversees the continuous improvement of Data Integrity standards to assure the completeness, consistency, and accuracy of GxP data, in alignment with regulatory requirements.
• Provide guidance to Resilience sites for remediation of deficiencies, as required.
• Oversees training of Resilience personnel on Data Integrity, Validation, Change Control, and relevant Quality SOPs and processes.
• Supports inspection readiness plans and interacts with regulatory agencies during inspections on validation and data integrity-related matters.
• Leads Communities of Practice (CoPs) across the Resilience network for the management of quality systems and driving continuous improvement.
• Develops and manages departmental goals and corresponding budgets in alignment with corporate vision and goals.
• Builds high-performance teams, mentors, and coaches personnel.Minimum Qualifications
  • Extensive experience in a pharmaceutical or biotechnology industry, with extensive experience in a quality oversight function
  • Comprehensive knowledge of global GMP regulatory requirements for qualification and validation
  • Hands-on experience with managing IT compliance and providing quality oversight of computerized systems validation.
  • Experience in leading Quality oversight of Digital Systems applications and platforms.
  • Demonstrated ability to set goals, and perform long-term project planning, team building, budgeting, and operational excellence.
  • Demonstrated experience with implementing systems and processes to assure data integrity.
  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
  • Proven strong oral and written communication skills with strong technical writing experience.
  • Ability to travel.Preferred Qualifications
    • Bachelor's degree of higher in Life Sciences, Engineering or related field
    • Broad experience of pharmaceutical/biotechnology industry experience, including Validation, IT and/or Quality leadership role; experience in biotechnology and cell & gene industry preferred
    • Experience with presentation of validation strategies and execution to auditors and inspectors.
    • Experience in application of lean methodologies and operational excellence to continuously improve.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 $160,000.00 - $227,500.00 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.

Keywords: Resilience, Boston , Technical Quality Lead, Accounting, Auditing , Boston, Massachusetts