Title: Plant Quality Assurance Manager
Location: US-South Carolina-Sumter
Job Number: QUA101CT
JOB SUMMARY
The Plant Quality Assurance Manager Serves as the Plant Management Representative and as a member of the site leadership team with responsibility for maintaining a quality system that meets all applicable regulatory requirements and ensuring that materials produced by the plant conform to established BD specifications. Departments consist of cost centers 4300 (Quality Engineering and period cost), 4530 (Microbiology and Chemistry Lab), and 4620 (indirect cost).
ESSENTIAL FUNCTIONS
* As a member of the PAS quality leadership team, the plant quality assurance manager is responsible for contributing towards and supporting the unit quality objectives and initiatives including the standardization and simplification of quality systems.
* Establishes plant quality goals and objectives, monitors progress towards meeting these goals and objectives and takes action necessary to address unfavorable trends. Ensures rapid communication and transparency of emerging quality issues among the plant leadership team and unit quality leadership.
* Ensures that plant quality assurance policies and procedures comply with PAS unit and all relevant applicable regulatory requirements, such as FDA/GMP/ISO. In addition, suggests improvements to unit policies and procedures as necessary.
* As management representative, meets and escorts regulatory agency inspectors such as FDA & ISO, customer visits and audits, and unit or corporate auditors. Maintains records of all required licenses, permits and registrations as required by regulatory agencies and follows up on renewals and compliance with stated conditions. May delegate the Authority to Accept Notice of Inspection (FDA form 482) on behalf of the Plant Quality Assurance Manager.
* Ensures that laboratories used to test product maintain a reliable and consistent level of operation and an adequate stock of laboratory reagents, supplies, instruments and tools.
* Accountable for adequacy and availability of quality engineering resources to support quality assurance activities including trending and analysis of quality data.
* The Plant Quality Assurance Manager is responsible for establishing and maintaining the plant quality system and ensuring that the following elements are effective:
Incoming materials and release of final product – all testing conforms to established specifications, inspections are completed and documentation maintained per established procedures. Responsible for auditing device history records and associated testing records and assures that that documentation is properly recorded prior to authorizing the release of raw materials and finished goods. Maintains a library of Device History Records and retained samples, as directed by FDA/GMP/ISO regulations.
Calibration – the plant wide calibration program including the frequency and the documentation comply with currently approved procedures and with FDA/GMP/ISO guidelines.
Validation - new processes and process changes, including process, molding, software and AME, are properly validated, are supported by approved validation protocols, and that validation reports are approved utilizing appropriate supporting documentation.
Documentation – plant quality system and manufacturing documentation is maintained with currently approved versions, as established by the PAS unit ECO procedures. Assures proper security of master records and officially distributed copies, and that obsolete or earlier versions of the documents are removed from users and destroyed.
Internal Audits - periodic internal audits are conducted to assure compliance with currently approved procedures, policies and FDA/GMP/ISO regulations.
Supplier Management – supports periodic vendor audits to maintain the vendor rating programs and that raw material quality meets or exceeds established specifications.
Customer Complaints – customer complaints (PIRS) are properly investigated for the products manufactured at the plant. Assures prompt investigation, resolution, corrective action and reply actions, ensuring that relevant associated documentation is completed.
Management Review – facilitates periodic management reviews to verify the suitability and effectiveness of the quality system to meet the BD quality policy and plant quality objectives.
CAPA – provides leadership to ensure proper management focus on CAPA, appropriate quality issues are elevated to a CAPA, adequate resources are available to manage CAPAs and root causes are identified and effectively addressed to prevent recurrence.
Change control – plant changes are properly reviewed and approved prior to execution and all appropriate verification and/or validation activities are completed prior to implementing changes.
Sterilization – proper expertise is available to manage sterilization activities and product meets sterility claims.
Environmental Monitoring – an effective environmental monitoring program is documented, executed and recorded.
Graphics / Labeling – an effective process is used to manage labeling activities including storage, inspection, label integrity and control.
Nonconforming Materials – an effective and efficient process exists to document, evaluate, segregate and disposition nonconforming product. The Plant Quality Assurance Manager is accountable for disposition of nonconforming materials.
Training – an effective and efficient process is in place to identify required competencies for each defined role and that associates are competent to perform their assigned roles.
* The Plant Quality Assurance Manager also supports plant activities such as:
Prepares budgets and maintains a cost control under their areas of responsibilities.
Assists and contributes to the cost reduction, process improvement, accident prevention, and environmental awareness programs and projects.
Evaluating and reporting the performance of the Quality Management System and the needs for improvement to Management.
ADDITIONAL RESPONSIBILITIES
Accountability
Accountable for the effective and timely release of finished product in accordance with FDA, ISO, Unit and local regulatory requirements.
Decisions related to releasing product where if an error in judgment as to sterility and/or quality was made, could lead to a significant impact on the company’s reputation, market position or costs.
Accountable for identification and establishment of appropriate systems and policies to support FDA and GMP/ISO Compliance.
Responsible for the administration of the Plant’s Quality Assurance Department Budget.
Manages work related confidential data. Must be very discreet when releasing information whose disclosure could affect internal relationships.
Mental Demand
Needs to apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions. Interprets drawings and technical instructions furnished in written or oral form. Prepares business letters, expositions, summaries, and reports, using standard formats and conforming to rules of punctuation and grammar. Participates in panel discussions, prepares and delivers presentations. Conduct training sessions. Communicate verbal instructions and requirements in clear, effective manner.
Qualifications:
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Bachelor's degree required. Prefer degree in Science, Engineering, or related technical discipline. Minimum seven (7) years experience in Quality Assurance, with three (3) years supervisory experience. Ideal candidate will have pharmaceutical and/or medical device experience. Experience with GMP/ISO compliance and documentation, and FDA Regulations.
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Knowledge of manufacturing systems, medical products and related materials, quality testing and quality auditing.
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Six Sigma or Lean certification desired.
* Certification CQM,CQE,CQA and/or CSSBB preferred.
* Travel, sometimes extensively, may be required.
Job: Quality Management