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Compliance Manager

Application Deadline: March 31, 2020


Job Summary / Overview:
We are seeking a highly experienced Regulatory Compliance Manager to provide leadership within the Quality organization with responsibility for Sagent’s inspection readiness program.
This is a Senior role within Quality Systems providing leadership for FDA and Health Canada regulatory compliance. This person will lead assessments to ensure that Sagent manufacturing sites are compliant with FDA and Health Canada regulations and gather information from manufacturing partners to identify and mitigate risks to Sagent products. This includes benchmarking and reviewing cGMP requirements to ensure compliance with regulations. The position requires up to 25% travel out of state and possibly out of the country.

Key Duties & Responsibilities:
• Provide regulatory compliance leadership within the Quality organization
• Prepare Schaumburg, Raleigh, Montreal, and SterRx sites for regulatory inspections
• Audit administration or scribe during FDA inspections
• Write responses
• Execute commitments made from inspections
• Perform risk assessments for CMO FDA inspections and assess Sagent product impact and supplier status
• Train other employees (audit readiness, GMP Refresher, or topic training)
• Lead cross-site projects with Nichi Iko, Omega, or SterRx.
• Lead IT Quality System integration projects
• Gather information and support investigations in support of required Field Alerts and Recalls.
• Support the Management Review process by compiling, and trending quality data.
• Perform Sagent internal audits to identify potential risks, recommend and implement solutions
• Communicate updates to US and other international standards to Sagent leadership
• Work closely with manufacturing partners to ensure compliance with all regulations

Knowledge, Skills and Abilities:
• Demonstrated experience in Quality program leadership
• Significant experience with the FDA and Health Canada
• In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines.
• Proficient with electronic quality management systems for complaints, change control, and training
• Possess strong organizational skills for prioritizing workload and responsibilities
• Ability to influence in a cross-functional team environment and a flexible team-oriented perspective
• Organizational and project management skills to support quality improvement projects.
• Strong written and verbal communication, interpersonal, negotiations and problem-solving skills
• Proficient with PC-based word processors and spreadsheets
• Ability to be and independent working manager with little oversight

Minimum and Preferred Qualifications:
• At least 5 years of progressively challenging QA/QC experience in the pharmaceutical or related industry
• At least 2 years of FDA and other regulatory agency inspection experience
• Preferred qualifications: project management and process improvement experience
• Preferred qualifications: experience implementing quality systems

Education / Certifications:
Bachelor of Science degree in Chemistry, Biology, Pharmacy, or related science field.

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