Responsible for directing the Quality Assurance Compliance functions for the Ohio site. Function includes, but not limited to Internal GMP Auditing, Data Integrity Reviews, Document Control and Records Management, Compliance Training, Complaint Handling, APQR, hosting Corporate, US and OUS Regulatory Inspections and performing external vendor/supplier audits as required.
- Responsible for the site’s GMP internal auditing program.
- Hosts all Corporate, U.S. and Outside United States Regulatory Agency inspections. Tracks and ensures compliance for any regulatory agency commitments.
- Provides input to the Annual Product Quality Review (APQR), management reviews and DIR’s (data integrity review) of site regulatory submission data as well as ensuring site Quality Systems are consistent with Company policies, procedures and specifications.
- Responsible for the site’s QA Document Control and Records Management program.
- Responsible for the site’s GMP and Compliance Training Program.
- Trend and analyze data from Quality Systems to ensure that relevant metrics meet site and corporate objectives.
- Assist in preparing a Quality department budget.
- Perform external vendor/supplier audits as required.
- Coordinate Product Complaint and HHE evaluations.
- Prepare and present technical and quality system program information to management.
- Develop strategies and programs for the improvement of productivity and efficiency of the various quality system processes.
- Develop new approaches to solving problems identified during quality system activities.
- Facilitate employee teams to build cohesiveness and improve the overall results of the respective teams’ tasks.
- Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GMP regulations
- Must easily interact with multiple departments, individual contributors and management levels.
- Bachelor’s degree or equivalent from accredited university.
- BS in science preferred with at least 15 years experience in the pharmaceutical industry with a minimum of 5 years direct experience conducting QA oversight activities.
- Aseptic manufacturing and filling experience required.
- Experience interacting with third parties (e.g., contract service providers) is preferred.
- Knowledgeable in FDA and non-US quality regulations, guidelines and standards is essential.
- Managerial experience required.
- Experience and knowledge with managing document control systems.
- Necessary characteristics include: being a self-starter, goal-oriented, attention to detail, team-oriented, ability to have positive interactions with other professionals without being critical and ability to multi-task. Ability to present and interpret data for management and staff. Excellent communication, technical writing, decision-making and people skills.
Ability to sit for extended periods of time reviewing and generating electronic and written data. Ability to manage a fast paced operation running 24/7 that includes a dedicated group of Quality minded professionals.
Frequently use a computer keyboard, PDA or other electronic device.
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA reports and other documents.
L aboratory, Manufacturing and Office environment.