Associate Director/Director (GCP) Quality Assurance
Sucampo Pharmaceuticals, Inc. (SPI) is currently searching for an Associate Director/Director (GCP) Quality Assurance for the US office located in Rockville, Maryland. SPI is a global biopharmaceutical company focused on innovative research and development of proprietary drugs to treat gastrointestinal, ophthalmic and oncology-based inflammatory disorders. Sucampo has a marketed product - AMITIZA® - and a pipeline including lifecycle management and clinical development programs. Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the United Kingdom.
Under the direction of the VP, Global Quality, the Associate Director/Director (GCP) Quality Assurance is responsible for developing, maintaining and improving the Global Quality Management System which supports the Company’s investigational and commercial products. This includes management of quality systems such as document control, training, CAPA, deviation, and change control. This position will implement and manage the GCP Quality Assurance program for the conduct of clinical trials. The incumbent will manage and/or perform audits of studies, programs, processes, and systems to assure compliance with appropriate cGMP/GDP/GCP/GLP/GVP/computer validation regulations, guidelines, and standards. The incumbent should have a thorough understanding of all practices, however the primary focus for this role will be on GCP and GLP. This position provides secondary support to the manufacturing and supply chain process, as needed.
Document Control System:
• Assist functional areas in developing and implementing global/regional procedures to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
• Develop and/or revise corporate standard documents relating to GXPs such as quality manuals, policies, SOPs, work instructions, forms, reference documents, etc.
• Oversee/develop the GxP training program.
• Maintain personnel training and qualification records.
• Prepare training materials (e.g., PowerPoint presentations) and deliver orientation, remedial and periodic GxP training.
• Track training assignments and generate status reports.
Audits and Vendor Oversight:
• Implement the GCP Quality Assurance program for the conduct of clinical trials.
• Conduct and/or manage audits against GXP (e.g., cGMP/GDP/GCP/GLP/GVP/computer validation) standards, FDA/EMA/PMDA/ICH requirements, and other regulatory standards to ensure compliance to all relevant policies and procedures.
• Develop audit agenda, issue audit reports and facilitate timely closure of corrective actions.
• Perform audits of internal operations and suppliers/vendors.
• Manage the vendor qualification program.
• Develop and negotiate agreements with clients or business partners to establish quality standards for contracted or license services.
• Quality Metrics, CAPAs, Deviations, Change Management:
• Generate metrics and trending reports. Identify and mitigate gaps.
• Manage the CAPA, deviation and change control systems. Lead investigations to ensure appropriate root cause analysis and corrective action follow-up, as necessary.
• Ensure that manufacturing processes, specifications, packaging, labeling and stability programs for the companies’ products remain consistent with corporate objectives and regulatory agency compliance requirements.
• Review and approve written procedures, raw material and product specifications, master product and control records, and Annual Product Quality Reports.
• Approve commercial and clinical investigation medicinal product labels for release to production, ensuring proper quality and compliance standards are met, as required.
• Perform batch record reviews and product release.
• Assist in managing the Quality Assurance budget and expenses.
• Represent Quality Assurance in company project meetings to ensure regulatory and ethical compliance requirements.
• Promote communication among the team by leading regular meetings with pertinent updates and other developmental activities.
• Mentor and develop the assigned team by establishing and implementing performance measures.
• All other duties as assigned by the VP, Global Quality.
1. Bachelor’s degree required from an accredited university in scientific, pharmacy or related field.
2. Minimum of 7 years of experience in Quality Assurance or Regulatory Compliance, with at least 5 years of cGxP auditing experience, and at least 3 years project or resource management experience, or equivalent combination of education and experience.
3. Prior GCP Quality Assurance management experience in the biotech or pharmaceutical industry.
4. Working knowledge of regulatory compliance and QA issues within a pharmaceutical organization.
5. Experience in a global environment from a regulatory/GXP perspective.
6. Ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
7. Excellent oral and written communication. Strong interpersonal skills to effectively communicate with the team, peers, management and external contacts.
8. Proficient with interpreting and implementing cGxPs, FDA and ICH Regulations and guidelines.
9. Proven organizational and leadership skills to mentor and develop team to achieve Company goals.
10. Strong working knowledge of MS Office products including Word, Excel, Access, Outlook, PowerPoint, and Project.
11. Advanced working knowledge of SharePoint is preferred.
12. Knowledge of quality systems utilized in biotech/pharmaceutical industries.
13. Must be able to travel up to 25% of the time to audits and other Sucampo offices.
Sucampo Pharmaceuticals, Inc. offers a competitive salary and benefits package including 401(k) with a generous company match as well as company-paid parking or metro expenses. If this position meets your qualifications and interest, please submit your resume to: www.sucampo.com/careers
Sucampo Pharmaceuticals, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. Sucampo Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Sucampo participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United State