Sagent Pharmaceuticals - Schaumburg, IL

Quality Systems & Regulatory Compliance Manager

Sagent Pharmaceuticals is seeking a Quality Systems and Compliance Manager. This is a senior role within Quality Systems to provide direct and indirect leadership for FDA and other regulatory compliance. Lead assessments to ensure that contract manufacturing organizations (CMO) supplying product to Sagent Pharmaceuticals are compliant with FDA, Health Canada, and other regulations. Gather information from CMO partners to identify risks to Sagent products. Benchmark cGMP requirements to ensure compliance with regulations. This position requires a candidate with significant regulatory inspection experience to lead Sagent’s inspection readiness program. Manage personnel conducting the Supplier Audit Program, the Annual Product Review program, and Quality Agreement program.

Key Duties & Responsibilities:

• Regulatory Inspections:
  • Prepare and support Schaumburg for regulatory inspections
  • Inspection administration during FDA inspections and other regulatory inspections.
  • Write and review responses to regulatory inspections
  • Execute commitments made from inspections
• Perform risk assessments for CMO FDA inspections and assess Sagent product impact and supplier status
• CMO Oversight: perform CMO annual metrics and subsequent communication with CMO quality organizations
• Manage and report on Key Performance Indicator (KPI) Metrics and prepare and deliver the Quarterly Management Review to senior management. Support and compile Sagent’s KPI metric requirements and Management Review process by compiling, and trending quality data.
• This position provides regulatory compliance leadership within the Quality organization. This may include the following:
  • Training other employees (inspection readiness, GMP Refresher, or Subject Matter Expert training)
  • Leading cross-site projects with CMOs.
  • Managing IT Quality System integration projects
• Communicate updates of USA and international standards to Sagent leadership
• Maintenance and oversight of the following areas:
  • Complaints, Field Alerts and Recalls: Manage investigations in support of required Field Alerts and Recalls. Must adhere to all required timelines.
  • Internal Audit Program: Perform and/or support Sagent internal audits to identify potential risks, including approval of any final reports and CAPAs.
  • External Supplier Audit Program. Manage the Supplier Audit program: coordinate global audit schedule, including oversight of existing suppliers and the evaluation of prospective suppliers. This includes CMOs, API Suppliers, External Contract Laboratories, and other suppliers. Travel to perform external domestic supplier audits of key suppliers.
  • Quality Agreements: create/revise agreements when needed
  • Annual Product Review (APR): create APRs for Sagent-owned products and complete within the required timeframe

Knowledge or Experience:

• Comprehensive working knowledge of cGMP’s/FDA regulations, Quality systems, FDA Guidance documents, USP, ICH and other applicable laws and their interpretation, implementation.
• Proficient with PC-based word processors and spreadsheets.
• Proficient with electronic quality management systems for complaints, change control, and training such as Trackwise, ComplianceWire, Veeva software systems.
• Possesses strong organizational skills for prioritizing workload and responsibilities
• Leadership skills (leadership through influence)
• Strong written and verbal communication, interpersonal, negotiations and problem-solving skills required

Key Leadership Competencies:

• Able to see beyond the obvious, assess and anticipate potential problems and outcomes, facilitate decision making, problem resolution and negotiation skills.
• Effectively prioritize workload and manage time to complete assigned projects within established timelines and goals.
• Ability to supervise, lead, mentor, and develop others for future growth and development.
• Strong organizational skills with the ability to manage and excel with minimal supervision by senior staff.
• Builds strong relationships with peers and cross-functional colleagues outside of the core team in order to enable higher performance.
• Learns quickly in order to grasp onto the issues at hand and can change course when needed.
• Handles risk and ambiguity comfortably; ability to make high-quality decisions with less than perfect information.
• Ability to manage conflict and difficult conversations across all levels of employees in a constructive and transparent manner.
• Raises the bar and is never satisfied with status quo.
• Responsible for the overall well-being of the team/personnel. Encourages managers to develop subordinates. Encourages individual growth and development of employees by providing proper attention to personnel succession planning. Provide regular feedback to team members, in addition to completing annual performance reviews. Builds and maintains employee morale and motivation; fosters a diverse and inclusive workplace.

Minimum Qualifications / Experience:

• At least 8 years of progressive challenging QA/QC experience in the pharmaceutical or related industry.
• At least 5 years of FDA and other regulatory agency inspection experience.
• In-depth knowledge of current GMP and FDA trends and guidelines.
• Strong interpersonal communication skills required – verbal, written and presentation.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Organizational and project management skills to support quality improvement projects.
• Ability to work independently on projects with little oversight.
• Travel up to 15%

Education / Certifications:

• Bachelor of Science degree in Chemistry, Biology, Pharmacy, or related science field.

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, n ational origin, veteran status, physical or mental disability and sexual orientation.