Overview
Quality Manager Jobs in Bellevue, OH at Autokiniton
Role Overview
The Senior/Executive Director for Inspection Management, Risk Management and Compliance is accountable for providing the strategy and direction and is responsible for leading and managing the Inspection Readiness efforts for GxP-regulated areas, including systems managed by external vendors. This leader authors, trains and coordinates risk assessments across the GxP landscape. This leader is responsible for the data integrity strategy as part of Inspection Management. This role ensures Savara remains inspection-ready and will continue to evolve our company processes to identify and manage compliance issues and risks and appropriately escalate issues in a timely manner to senior management. Building strong relationships with internal stakeholders is vital to this role. This leader represents Quality to Savara business stakeholders in a business-facing capacity with both tactical and strategic focus areas, and is able to triage communication between business functions, internally and externally.
Core Responsibilities
Define the strategic plan for maintaining organizational inspection readiness across all organizational functions and external vendors.
Lead, implement and execute the Inspection Management program, including the creation of an inspection readiness scorecard across all GxP functions.
Manage all internal logistics (front and back-room) for GxP Inspections or audits of Savara.
Maintain and update inspection opening presentation materials and manage logistics, to ensure consistency and accuracy. Oversee continuous improvement of Inspection Management processes and activities, including policies, procedures, and training.
Provide company-wide training on inspection-related topics.
Accountable for the Quality Risk Management Program, implementing appropriate risk management principles using a risk based approach and provide training as necessary.
Accountable for the data integrity strategy across the GxP organizations.
Collaborate with stakeholders such as Global Technical Operations and Supply Chain, Clinical Operations, Clinical Development, and Regulatory Affairs, to ensure inspection preparedness, conduct compliance assessments, identify and mitigate compliance gaps, and offer guidance related to GxP processes.
Monitor current regulatory requirements, inform stakeholders of potential impacts, and initiate gap assessments as necessary
Serve as the Compliance QA Partner for inspection-readiness related to quality issues, initiatives, and projects.
Develop, track, and report compliance and inspection metrics, and escalate trends or significant findings to company management.
Assesses proposed corrective or preventive actions in response to audit or inspection findings, tracks and reports item closures, and timely escalates areas of risk or concern.
Supervisory Responsibilities
Interview, hire, and onboard direct reports
Develop talent and align on goals and development opportunities
Provide constructive and timely ongoing feedback
Motivate and direct work
Lead cross-functional teams, and manage, coach and grow direct reports
Required Qualifications
Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (CFR) related to GxP, ICH Guidelines, and Health Authority requirements.
Experience in the biotech or pharmaceutical industry managing Health Authorities during inspections and managing Customer/Business Partners during inspections is required.
Experience with managing the FDA’s Bioresearch Monitoring (BIMO) program inspections is preferred.
Proven experience with implementing a Quality Risk Management program, defining metrics and (preferred) defending the program to Health Authorities.
Working knowledge of the requirements of data integrity to provide training, and integrate into inspection management.
Experience in a virtual manufacturing environment; knowledge of large molecule and biologics is preferred.
Excellent verbal and written communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance
Diplomatic, tactful and detail-oriented with excellent critical reasoning skills
Strong independent judgment and problem solving skills
GXP Auditor certifications a plus
15+ years of progressive global quality/regulatory compliance background in pharma/biotech, with a hands-on role in quality operations and quality systems
Proven experience leading and managing team
Work Schedule and Location
This role will be remote within the United States. Occassional travel to the corporate office outside of Philadelphia, PA and as needed- travel to vendor locations domestically and internationally will be required. The employee must be able to work a US eastern time schedule.
Savara provides Comprehensive Benefits including:
Highly competitive medical, dental, and vision coverage
Flexible Spending Accounts for health care and dependent care expenses
Paid time off and paid holidays, including Dec 24-Jan 1
Paid parental leave
401k with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Savara’s compensation can include a base salary, bonus, and equity. This role can be filled either as a Director or Senior Director and the base salary range is $215,000 to $275,000.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company’s lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara’s management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
Title: Quality Manager
Company: Autokiniton
Location: Bellevue, OH
