Summary of Duties and Responsibilities
The Sr. Manager Compliance is responsible for leading global Complaint Management, Issue Escalation, Field Alert Compilation and Product Recall Management. In addition, the Sr. Manager Compliance owns the Global Standards/SOP’s and processes associated with Complaint Management, Issue Escalation, Field Alert Compilation and Product Recall Management, and ensures that these Global documents are kept current, aligned with industry norms and that the associated processes are continuously improved.
The Sr. Manager Compliance will engage with and influence stakeholders and staff across Impax to drive effective investigation and timely closure of complaints. Also, this individual will enable the analysis of complaint trends and will hold periodic Executive Complaint Review meetings to ensure management awareness and timely resolution of complaint related issues and trends. This individual will manage any external complaint call center needs and will ensure that appropriate metrics are developed and maintained to continuously monitor the health of the complaint system at Impax.
The Sr. Manager Compliance will lead the process (with cross functional teams) for escalation of Quality related issues, analysis of the issue and determination of field alert applicability. Where a field alert is required, this individual will compile the field alert for submission to the regulatory agency. In addition, this individual will manage any product recalls and will communicate with regulators in the event of such recalls.
Lead a group of individuals to effectively manage Global product complaints, field alerts, issue escalations and product recalls.
Lead global complaint trending and presentation of trends to Management
Develop, maintain and publish appropriate metrics that routinely measure the health of complaint management at Impax. Use the metrics to determine opportunities for process improvement
Own and keep current, the Global Standards and SOP’s associated with Complaint Management, Issue Escalation, Field Alert and Product Recall
Enable the escalation of quality issues, critical product quality complaints and facilitate the discussion that leads to a determination of whether a Field Alert Report or product recall is required or not.
Manage field alert compilation and product recalls
BS degree, preferably in a science-related field or MS with 8-10+ years of experience
8-12 years of experience and demonstrated progressive responsibility in quality assurance and/or regulatory compliance, with at least 3 years of people management experience.
Thorough knowledge of FDA cGMPs as described in 21 CFR Parts 210, 211, and 21CFR Part 11, applicable sections of EU GMP’s (Eudralex) and ICH requirements.
2-5 years of experience with managing product complaint systems in Pharma, Field Alert determination, compilation and submission, product recalls and at least exposure to general issue escalation processes.
DEA knowledge of schedule drugs is a plus.
Knowledge of pharmaceutical research and development processes
Requires knowledge/experience of word-processing, spreadsheet, and database applications
TrackWise tracking modules.
Excellent communication and facilitator skills needed to interact with stakeholders across Impax.
Time management and planning skills are essential. Requires the ability to work independently and complete assignments on time with minimal supervision and/or guidance.
Planning & Organizing skills including the ability to approach tasks in a methodical and systematic manner. Develop and implement a project plan and the ability to manage to the plan. Find new ways of organizing or planning work to accomplish tasks more efficiently.
Ability to lead a multi-disciplinary team and deliver team goals through the team. Collaborate with others to formulate team objectives and develop consensus for best outcome.
Critical thinking and problem solving skills.