Manager Quality Assurance

Versiti•Aurora, IL

19h

About The Position

This position must be independent from production associated activities in order to meet the cGMP definition of an independent Quality Unit and function in review, approval and release tasks as defined by the cGMP regulations. Responsible for establishing and implementing effective Quality systems to meet or exceed cGMP requirements. Ensures the activities and controls used to determine the accuracy and reliability of the establishment's personnel, equipment, reagents, operations and release or rejection of final product in the manufacturing of biomaterial products including their testing Collaborates with Center management to ensure compliance with all applicable regulations, laws, guidelines, standards and Company policies, and that the Center is "inspection ready" at all times Ensures all staff are trained and competently performing their duties as evidenced by the auditing of the program Leads investigations to determine root causes, corrective/preventative actions and appropriate review of resulting effectiveness checks Proactively facilitates communication and interdepartmental coordination resolving quality issues and to host audits, both internal and external.

Requirements

Bachelor's Degree required
Minimum of six years QA oversight of biological manufacturing operations, utilizing a risk-based approach to biologic material manufacturing, required
Working knowledge and experience practicing under a QMS preferred
Two or more years performing as a responsible cGMP Quality sign off for a regulated product preferred
Working knowledge of 21 CFR 210, 211 and 820 preferred
Demonstrated ability to work with remote resources across multiple sites preferred
Experience with batch record review, results outside of specifications, and CAPA investigations
Experienced with both Quality and production related documentation, line clearances, and status control of raw materials and finish product, approval of C of A’s, quarantine and release of in-process and finished goods.
Internal and external audit experience, preferred lead audit support
Strong understanding of FDA regulations as they apply to blood products or pharmaceuticals.
Positive, enthusiastic, and customer service oriented interpersonal skills
Ability to work as part of a high performing team and collaborate effectively with staff at all levels and establish highly functional relationships within and outside the company.
Excellent technical writing and verbal communication skills.
Domestic travel (~10%) as needed.
Strong oral, written and listening skills.
Ability to assess priorities and successfully manage workload to timelines.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Understanding of basic scientific/technical concepts and ability to analyze moderate to complex data and glean basic information from the data.
Previous experience with electronic quality systems such as for document control, training, and change control preferred.

Nice To Haves

Working knowledge and experience practicing under a QMS preferred
Two or more years performing as a responsible cGMP Quality sign off for a regulated product preferred
Working knowledge of 21 CFR 210, 211 and 820 preferred
Demonstrated ability to work with remote resources across multiple sites preferred
Internal and external audit experience, preferred lead audit support
Previous experience with electronic quality systems such as for document control, training, and change control preferred.

Responsibilities

Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), the organization’s QMS, compliance policies, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation.
Prepare regular reports to Management and corporate quality management as to the state of quality and systems at the Center.
Function as the responsible Quality Assurance reviewer to approve or reject final products before shipping, batch records, quarantine releases, rework, destruction and associated documentation such as Certificates of Analyses.
Manage site Quality Assurance program including but not limited to calibration management, monitoring of compliance to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of those KPIs, root cause and failure mode impact assessment and change management.
Working knowledge of the change management process and appropriately raise ideas for consideration for change locally and upward to quality and Center management.
Receive and provide feedback to staff on observations leading to improved adherence to cGMP regulations.
Report concerns or deficiencies to Center personnel and/or Center management immediately.
Review operations staff’s RCA, corrective actions and effectiveness checks to resolve audit observations and other non-compliance issues of deficiencies.
Lead and function as the key Quality representative for site supplier, customer and regulatory audits.
Lead Center’s review of findings, coordination of Corrective and Preventive Actions (CAPA), if needed and successful closure of audits in a timely fashion.
Utilize quality tools and applications to facilitate understanding of issues and documentation.
Conduct routine audits of internal procedures and documentation, as necessary.
Adhere to all HR policies and practices through fair and equitable treatment of all employees.
Communicate effectively with HR to ensure HR compliance and ensure Center management is doing the same.
Comply with all Federal, State and local regulatory laws, standards and guidelines.
Maintain confidentiality of all personnel, contributor and Center information.
Monitor CAPA’s and effectiveness checks to ensure issues are resolved.
Performs other duties as assigned
Complies with all policies and standards