Job description
OVERVIEW
Responsible for the administration of Quality Assurance systems related to monitoring of in-process production processes; release testing of incoming components and raw materials, review and approval of investigations and validation protocols and final reports. Responsible for the QA oversight of all QA Documentation and GMP Training of the facility. Responsible for QA oversight of production and laboratories activities, assuring that products are manufactured in compliance with cGMP, USP, FDA, EU guidelines and CFR 820 requirements for combination products and processes. Responsible for the final batch record review and final lot disposition. In the absence of the Sr. Director of Quality & Technical Affairs, assumes responsibilities for daily functional activities of the QA/QC division.
Supervisory responsibilities include supervision of (1) Quality Assurance & Sterility Assurance Manager for Operations In-Process QA, QA Incoming Components receipt and release, Sterility Assurance & Aseptic Technique and batch record review and release; (1) Quality Investigations Manager that oversee the review and approval of investigations, validation protocols, final reports, change controls and Particle Action Limit program; (1) QA Documentation Manager for batch record issuance, SOPs, change controls and the site’s GMP Training Program. Supervisory responsibilities for directing and managing people and systems that assure product quality and conformance to regulations and company policies. Lead efforts toward continuous Quality improvements.
- Directs the Incoming QA and QA Operations departments.
- Identify and direct activities to ensure compliance to FDA regulation and other State, Federal and International regulatory agencies.
- Participates and assists with developing/deploying of various quality systems (e.g. MIR metric review, CAPA review) that ensure products conform to defined requirements.
- Ensures that QA perspective for engineering reports (FRSs, commissioning documents), validation protocols and final reports including but not limited to equipment, process/product protocols is given.
- Periodically reviews the suitability and effectiveness of the quality systems.
- Provides QA oversight of the entire Manufacturing site.
- Provides QA oversight for the required guidelines for CFR 820 to ensure that the combination products and processes for the prefilled syringe (PFS) and intravenous bag (IV Bag) platforms are manufactured and monitored within the required guidelines.
- Provides QA guidance for the Analytical and Product Technology Transfer for products being developed in R&D to include input for the manufacturing and processes required for the drug product filled into vials, ampuls, PFS, IV bags and emulsions.
- Develops budget and monitors expenditures.
- Makes recommendations for corrective action necessary to assure conformity with quality specifications.
- Assures finished products conform to government and client company standards and satisfies GMP regulations.
- Interacts with customers and regulators concerning the quality of products, systems, and processes.
- Identify and drive quality initiatives.
- Directs personnel responsible for establishing policies, guidelines, and procedures, and makes final accept/ rework/reject decisions on compounding, in-process filling, and inspection/packaging monitoring.
- Direct and implement the organization’s quality improvement plan in accordance with the mission statement and strategic goals of the organization, federal and state laws and regulations, and standards.
- Assumes responsibilities of final batch record review and final product release and disposition.
- Lead and participate in cross-functional teams to drive improvements in processes that impact compliance to regulations and standards.
- Provide QA perspective and final approval for manufacturing investigations. Assures timely review/completion of all investigations. Assures adequate corrective action, commitment tracking, and trending is completed for all investigations.
- Assumes responsibilities of daily functional activities and has authority to make decisions for the QA/QC division in absence of the Sr. Director, Quality & Technical Affairs. Represents QA/QC in external and internal meetings.
- Actively participates on various project teams and committees such as Operational Excellence, CAPA Review, Site Management, R&D Product Transfers and Quality Council.
- Develops personnel, administers budget, plans for future resource needs with regards to personnel, equipment, and facilities.
- Assists with FDA and other regulatory agencies’ inspections and pre/post approval inspections.
- Responsible for the biennial SOP review and the site’s GMP training metric, change control and timely issuance of commercial and developmental batch records.
- Responsible for final approval of all change control activities (e.g. equipment, facility, master batch record). Responsible for final QA approval engineering design/developmental documents and maintenance documents.
- Manage overall coaching, training, development and succession planning for the department. Ensures that Performance Reviews are completed in a timely manner, as well as development planning activities.
- Bachelor of Science in a science. Advanced degree preferred.
- Minimum of 10 years’ experience in Quality and/or Manufacturing within FDA/other regulatory environments of parenteral products.
- Experience in manufacturing Injectables Quality Assurance required.
- Must possess a strong knowledge of quality systems for parenteral drug products per CFR 210/211 and combination products per CFR 820 requirements related to prefilled syringe and intravenous bag manufacturing.
- Must have organizational skills and management skills. Must possess strong leadership skills.
- Experience in sterile manufacturing of aseptically filled and terminally sterilized processes, sterility assurance and sterilization validation.
- Demonstrated ability to direct a department, oversee projects/teams.
- Must possess strong analytical and problem-solving skills.
What We Offer
- Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match up to 6% of your contributions
- 23 vacation/personal days
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
- Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.
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