Oversee day to day operations of the Quality Control Laboratory, Qualification and Development and Validation Departments while ensuring adherence to cGMP’s and CGLP’s and safety requirements and provide senior technical leadership in Quality Control to enable the development, validation, and optimization of analytical methods in support of both internal pharmaceutical development and third-party projects. Identify and implement systems needed to support Quality Control/Development activities in a regulated environment. Ensure QC computer systems are validated, and data integrity maintained.

• Served as head of QC, managing QC lab. Facilitated operations by supporting production, raw materials, and finished product releases as well as stability testing for Commercial and Clinical and managing Microbiology testing, Contract Lab testing and Metrology functions. Supported and engaged 60-plus clients. • Managed over 35 individuals in QC laboratory (including five direct report managers).• Facilitated project management efforts, including working with clients and vendors, handling laboratory compliance, overseeing FDA and client audits, developing responses to observations, and promoting safety awareness.• Led daily hurdle (Tier 1) morning staff meetings.• Oversaw laboratory investigations (i.e., OOS, OOT, OOC, and lab deviations), using Track Wise.• Conducted daily production / supply chain meetings (Tier 2) as well as updates.• Led preparation of laboratory metrics for monthly and quarterly QMS meetings. Managed laboratory investigation trending.• Oversaw CAPA, change management, and effectiveness checks.• Guided cycle time reduction in testing, releases, and audits. Reduced overtime. • Drove reduction in laboratory deviations and errors via effective training and cross-functional training.• Review and approval of technical documents such as Process Validation, Specifications, Test Methods, Method Validation, Transfer Protocols, Change Control, and APR (annual product review).• Hiring and discipline actions and terminations.

• Acted as key regulatory compliance liaison to interface with regulatory agencies during audits of lab operations. Handled US FDA inspections, including audits conducted by outside consultants and customers. • Directed and prioritized quality control and analytical method validation. Supervised and managed 50 individuals in the QC laboratory (including five direct reports). • Reviewed and approved laboratory documents, including SOPs, change control, investigations, planned events and deviations, ANDA submissions, deficiency responses, and environmental monitoring program.• Established policy and adherence to FDA data integrity and compliance with drug cGMP.• Participated in QMS and MRMs to track and monitor the progress of quality metrics and compliance.• Led establishment of raw material, in-process and finished product, and stability specifications as well as expiration dating on commercial products to ensure regulatory compliance.• Emphasized timely release of raw materials, in-process and finished products, and stability testing with timely investigations initiations, write-ups, and closures.• Implemented raw material reduced testing program for qualified vendors.• Review and approval of elemental impurity risk assessment as per ICH Q3D-USP <232> and NDMA assessments. • Managed analytical instrument and equipment calibration and qualification programs.• Facilitated microbial testing management at the contract lab. • Drove continuous improvements in GDP documentation practices and training programs.• Evaluated and qualified alternate sources of API and prepared for PAS filings with regulatory affairs.• Led the development of short- and long-term goals of the QC lab.• Coordinated (analytical) technology transfer with various API sources and contract development sites.• Oversaw capital expenditure and budget preparation for lab operations.• Aligned resources with business unit needs to ensure on-time execution and release of testing results.

• Directed and prioritized primary activities for quality control and analytical method validation. • Managed 70-plus individuals in the QC laboratory (including five direct report managers).