Manager - Quality Compliance

Job Title:YRC99H– Manager, Quality Compliance

Brief Description: The Quality Compliance Manager is responsible for coordinating and providing oversight to the Quality Compliance department’s daily activities including audit planning and management, audit responses, CAPA management, and document management. The Quality Compliance Manager is responsible for ensuring the Company’s quality systems and procedures meet US and international regulatory requirements (e.g., FDA/CRF, GxP, EMA, HRA, EU GVP, GCP) as applicable for business. The Quality Compliance Manager ensures that the department meets its SOP and contractual obligations and timelines. The Quality Compliance Manager identifies and tracks continuous improvement projects throughout the department. Other duties as assigned. Travel: 20-30%, expected.

Specific job duties:

• Ensure annual risk assessments and audit plans are completed according to internal SOPs.
• Coordinate Quality Compliance support and provide oversight for client and regulatory audits. Host audits where necessary.
• Provide oversight and perform internal, third-party supplier, REMS, and investigator site audits.
• Ensure scheduled audits are completed within required timeframes.
• Manage daily activities and issues within the Quality Compliance department.
• Manage direct reports within the Quality Compliance department including goal setting, performance evaluations/feedback, and coaching/disciplinary activities.
• Ensure timelines for Quality Compliance deliverables are met.
• Manage Quality Compliance-related metrics.
• Participate in Quality Management Council.
• Provide oversight and guidance for CAPA management and effectiveness program.
• Ensure document review process occurs according to SOPs.
• Serve as subject matter expert for escalations related to Quality Compliance issues across internal and external stakeholders.
• Identify and facilitate process improvement initiatives.
• Ensure SOPs and policies are reviewed and/or updated according to required timelines.
• Provide regular updates to Quality Compliance leadership regarding department status and activities.
• Assist with department deliverables (e.g., clinical study reports, protocol reviews, safety reports, audit reports and responses, CAPA plans, CAPA effectiveness checks) to ensure timelines met.
• Ensure all department activities are performed in accordance with applicable regulations.
• Triage and investigate, where appropriate, Compliance Hotline inquiries.
• Other tasks, as needed and/or assigned.
• Supervisory Responsibility:
• Position may require management of direct reports within the Quality Compliance department.

Desired Skills and Qualifications:

• Bachelor’s degree required preferably in Life Sciences, Clinical, or Business area of study with 5 – 8 years of quality assurance/compliance/auditing experience in a regulated industry (e.g., pharma, medical device, food)OR Master’s degree and 3 years quality assurance/compliance/auditing experience within a regulated industry (e.g., pharma, medical device, food).
• Preferably at least 1 year of previous managerial/supervisory experience (i.e., experience managing teams and/or staff).
• Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint.
• Knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GxP, FDA/CFR, EMA, MHRA, EU GVP)
• Experience in management of the corrective and preventive action (CAPA) lifecycle
• Experience in Quality Management Systems
• Experience hosting client audits/regulatory inspections
• Experience conducting internal process, third-party supplier, investigator site, REMS, pharmacovigilance audits.
• Experience in management of standard operating procedures (SOPs)/policies
• Experience in implementation and management of process improvement
• Excellent verbal presentation and written communications skills.
• Proven interpersonal and relationship building skills.
• Previous experience with clients, projects, and/or vendor management.
• Proven skills in planning, analysis, and creative problem solving.
• Demonstrated ability to:
  • Always be honest with a high level of integrity.
  • Communicate effectively and professionally across all levels of the organization, with clients/sponsors, and with regulatory inspectors.
  • Manage multiple tasks and competing priorities in accordance with business needs.
  • Be a team player who motivates and educates other team members.
  • Work independently.
  • Plan, implement and support systems in a complex environment.
  • Translate technical language to lay audiences.
  • Be detailed oriented.
  • Ensure confidentiality and discretion.
• Proven ability to collaborate with and build relationships with key stakeholders.
• Preferred exposure to software application development and maintenance.
• Experience with clinical document review (e.g., clinical study reports, protocols, safety reports, project-specific procedures).

Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. 

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• Flexible work environment
• Discretionary PTO (Paid Time Off) 
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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