Nature and Scope

The Quality Assurance Manager, External Manufacturing will be primarily responsible for supporting GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. This position will act as the lead Quality point of contact for assigned projects. Primary responsibilities of this position include support for all aspects of pharmaceutical lifecycle management including process development, commercial manufacturing and testing/release of drug product. Activities include working directly with Contract Manufacturing Organizations (CMO), change management, validation, batch dispositions, investigations, APR completion and supplier change decisions.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, Quality Agreements, regulatory standards and the American Regent Quality Management System.
• Ensure high performance of third-party finished product contract manufacturers by establishing Quality KPI scorecard with regard to compliance and performance metrics.
• Drives timely decisions and facilitates active communication and information flow between contract manufacturer and American Regent functional teams.
• Ensure Quality and Compliance related matters meet appropriate GMP and regulatory requirements to ensure product is safe, pure, and effective.
• Supports American Regent Supply Chain Operations related to commercial product distribution and timely launch of new products by:
  • Serving as the Quality lead for technical transfer activities at external manufacturing partners.
  • Supporting manufacturing activities related to regulatory filings (i.e., on-site presence for engineering, validation, registration batch manufacturing, timely review, and approval of documents, etc.)
  • Facilitating approval or release of commercial product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and /or contractual agreements.
• Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action.
• Investigating and determining the need for and managing any field alerts or recalls/withdrawals of company products manufactured by third party contract manufacturers.
• Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation.
• Performing on-site visits during manufacturing/packaging of American Regent products and create quality business review process.
• Initiate and attend periodic meetings with CMO as ARI QA representative.
• Make quality decision on CMO/Suppliers related tasks and events.
• Provide status update on CMP related tasks and action items to multiple internal departments.
• Monitor/track the relationship between ARI batches to CMO batches.
• Provide information and documentation needed for shipping products between ARI and CMOs.
• Monitor/track/trend batch disposition from CMOs. Create CMO related tasks tracking documents, update on time and share with multiple departments.
• Review and approve CMO/Suppliers executed batch records and batch disposition documents.
• Create and provide various CMO requested documents.
• Notify CMOs for any internal events require 3rd party notifications and follow up on 3rd party review status as applicable.
• Review and approve ARI batch disposition documents and create CoC.
• Support regulatory agency inspections.
• Routinely interact and establish solid working relationships with all functional areas at American Regent.
• Participating in Regulatory and American Regent inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites.
• Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary.
• Perform any other tasks/duties as assigned by management.
• Developing and revising necessary company policies and procedures to support management of third-party contract manufacturers and external service providers.
• Develops and fosters positive relationships with CMO while holding CMOs accountable.
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's Degree in Engineering or science discipline or related field required.
• Minimum 8 years' experience in Pharmaceutical QA preferred, with preferences of External Quality Management and sterile injectables.
• Strong working knowledge of current Good Manufacturing Practices, FDA and ICH Q8/9/10/12 guidelines.
• Direct experience participating and supporting regulatory inspections and submissions preferred.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
• Ability to travel domestically or internationally 5-10% preferred.
• Experience with Microsoft Office.
• Excellent organizational, interpersonal, and communion skills (oral and written).
• Demonstrated experience with use/governance of electronic Quality Systems preferred.

Expected Salary Range:

$97,750-$120,000

The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .