Sr Mgr, Commercial Quality

Description

• Responsible to execute the formal market action decision as dictated by Senior Quality Unit Management and the Market Action Committee and author Product Recall Letter. Circulate draft Recall Letter to Quality Unit Management for review and compile and resolve suggestions/comments.
• Work with Regional FDA District Recall Coordinator to coordinate the FDA’s review of the Recall Letter.
• Monitor the Notification to Authorities for potential notifications to FDA of any potential Field Alert Reports, Biological Product Deviation Reports, Medical Device Reports, Illegitimate products reporting, Drug Shortage Reporting and Recalls.
• Utilize the Enterprise Resource Planning System to identify remaining inventory within Teva Control as well as all customers to whom product was distributed to.
• Send Recall Letters to all Customers and applicable Business Partners
• Liaison with Teva’s Contracted Recall Service Provider to ensure proper handling, reconciliation, and destruction of products returned for a recall event. Ensure Recall Effectiveness Checks are performed.
• Submit Recall Update Progress information to the FDA monthly
• Submit information for closure of the Recall to FDA.
• Perform activities necessary to communicate specific Drug Shortage events and periodic updates to FDA Drug Shortage Staff. Work with Commercial team on obtaining information for periodic updates to FDA.
• Provide weekly updates to FDA Drug Shortage Staff (DSS), respond to request for information by FDA DSS and update the FDA DSS Drug Shortage Webpage on a biweekly basis based on information obtained from Supply Chain and Commercial teams. Keep management informed of critical potential supply interruptions that could affect the Company reputation.
• Prepare and provide weekly Supply Interruption report.
• Conduct the applicability and gap assessment for the CORP STDs for the Quality Systems & Regulatory Compliance Dept. Author new/enhance existing SOPs to close gaps by the Effective Date of the CORP STD. Ensure the GAP assessment is performed within deadlines to ensure updates are completed prior to the Effective date of the CORP STD.
• Work with various Quality Systems and Process Owners to ensure North Wales/Parsippany sites are Inspection Ready.
• Provide support to Inspection related activities including but not limited to: Scribing Notes from Inspection conversations, performing Back Room coordination activities, retrieving/reviewing requested records, daily summary notes, etc.
• Provide Regulatory Agency Inspection support to Teva sites who supply products to USA market.
• Lead and/or support internal audits, including audit scheduling, audit planning, conducting audits, and audit reporting

Qualifications

• Bachelor's Degree in a scientific discipline
• A minimum of 5 years of Quality Compliance Leadership related experience in the Pharmaceutical (or related) industries
• Functional knowledge concerning Pharmaceutical Quality Assurance, Quality Control and Regulatory Compliance
• Excellent GMP knowledge
• Strong knowledge of Excel; knowledge of Veeva, and/or SAP is a plus
• Excellent written communication skills
• Teamwork and negotiation skills
• Ability to professionally and successfully interact with all levels of management
• Ability to juggle, correctly prioritize and advance multiple activities and projects simultaneously