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    "requisitionDescription": "<div><div><p id=\"isPasted\"><strong>SUMMARY:&nbsp;</strong></p><p>The Senior Director of Operations provides strategic leadership and direction for all operational departments at the facility, ensuring alignment with organizational goals and objectives. This position is responsible for driving operational excellence, optimizing resource utilization, fostering a culture of continuous improvement, and maintaining strict compliance with cGMP regulations. The Senior Director oversees manufacturing, packaging, maintenance, and shipping/receiving, ensuring customer delivery commitments are met while maximizing efficiency, quality, and safety. This role also involves proactive engagement with senior leadership to shape operational strategies, lead key initiatives, and develop talent within the operations team. Additionally, this role will assume leadership for new products and Capital Expenditure (Capex) initiatives, including client engagement and cross functional relationship building, driving quantifiable improvements in productivity, quality, and cost effectiveness. &nbsp;</p><p><strong>&nbsp;</strong></p><p><strong>RESPONSIBILITIES:&nbsp;</strong></p><ul type=\"disc\"><li>Manage teams ranging from 10 to over 200 employees, utilizing decision-making of problem-solving skills to identify cost saving opportunities and ensure lead time compliance across all operations.&nbsp;</li><li>Ensure compliance with FDA, and DEA regulations during manufacturing processes, proactively identifying and mitigating regulatory risks. &nbsp;</li><li>Oversee project budgets and conduct financial analyses to enhance profitability, while fostering collaboration among stakeholders and mentoring teams.&nbsp;</li><li>Provide strategic leadership and direction for all operational departments, aligning with overall organizational strategy and objectives, including identifying opportunities for expansion and improvement.&nbsp;</li><li>Develop, manage, and oversee manufacturing, packaging, maintenance, and shipping/receiving budgets, ensuring cost-effectiveness and alignment with financial targets, and proactively seeking opportunities for cost optimization.</li><li>Ensure customer delivery commitments are consistently met by developing and implementing robust planning and execution strategies.</li><li>Direct workflow optimization initiatives, including facility layouts, product flow and storage optimization, leveraging best practices.&nbsp;</li><li>Establish, manage and monitor Key Performance Indicators (KPI&#39;s) related to operations, driving continuous improvement through proactive analysis, action plan implementation, and performance tracking to achieve strategic goals.</li></ul><ul><li>Develop comprehensive capacity models for all operational resources (machines, people, rooms, etc.) and make data-driven adjustments to meet current and future customer needs while optimizing resource utilization and planning for strategic growth.</li><li>Ensure all operational processes are supported by comprehensive Standard Operating Procedures (SOPs) that meet or exceed all applicable cGMP requirements as outlined by the Code of Federal Regulations (CFRs).</li></ul><ul type=\"disc\"><li>Collaborate closely with Quality Assurance group in preparation for and participation in facility audit, ensuring audit readiness and addressing any findings promptly and effectively.&nbsp;</li><li>Oversee the development and execution of comprehensive training program for all operations staff, including the creation of training plans, matrices, curricula &amp; training methods and the delivery of effective training to build a highly skilled and competent team.</li></ul><ul><li>Champion a quality-focused culture within operations, ensuring quality is integrated into all processes and practices, and that quality commitments are consistently met.</li></ul><ul type=\"disc\"><li>Lead the recommendation of measures to improve production methods, equipment setup, operational procedures, and adherence to Standard Operating Procedures.&nbsp;</li><li>Lead the selection, justification, and implementation of new equipment and technologies for operation related functions ensuring alignment with business needs and compliance requirements through ROI calculations or other appropriate analyses.&nbsp;</li><li>Develop lead, and support continual improvement efforts throughout operations, fostering a culture of innovation, problem-solving, and proactive process enhancement.</li><li>Provide guidance, coaching and development to direct reports, fostering professional growth and enhancing their leadership capabilities and actively mentor emerging leaders withing the organization.</li><li>Establish and maintain succession planning to ensure uninterrupted operational capabilities and leadership continuity, to proactively identify and develop talent for future leadership roles.</li><li>Manage hiring, performance reviews, merit recommendations, and disciplinary actions for direct reports and reports and employees throughout the various Operations departments, ensuring fair and consistent application of HR and Company policies.&nbsp;</li><li>Facilitate inter-departmental collaborations to proactively analyze and resolve complex bottlenecks and problems, fostering teamwork and effective problem-solving across the organization.&nbsp;</li><li>Work closely with senior managers/directors in all departments to foster a collaborative and supportive environment that enables the organization to meet its deliverables safely and with the highest quality.&nbsp;</li><li>Oversee vendor relationships and contracts related to operations, ensuring optimal service levels, cost-effectiveness, and alignment with business objectives, and strategically negotiate contracts to maximize value.</li><li>Lead and enforce a comprehensive safety program aligned with OSHA and cGMP standards to ensure a safe working environment.</li><li>Oversee thorough investigation of safety incidents, ensuring timely corrective and preventive actions (CAPAs) are implemented effectively.</li><li>Promote a culture of safety awareness and accountability across all operations teams. &nbsp;</li><li>Serve as the primary operational lead for new products introductions and Capital Expenditure (Capex) projects, including direct client engagement and communication. This includes overseeing major buildouts and facility expansion projects, from conceptual design to operational readiness, and ensuring successful commercialization of pre-approval products.&nbsp;</li><li>Actively build and maintain strong collaborative relationships with the Quality Assurance team and other critical cross-functional departments to ensure seamless operational alignment and support. This also includes engaging with external regulatory agencies and industry experts.&nbsp;</li><li>Other duties as required, including strategic projects assigned by the EVP Rx Operations.</li></ul><p>&nbsp;</p><p><strong>QUALIFICATIONS:</strong></p><ul type=\"disc\"><li>Bachelor&rsquo;s Degree required. Master&rsquo;s degree in operational or scientific discipline preferred&nbsp;</li><li>15+ years of progressive experience in an FDA cGMP regulated environment, with a strong preference for pharmaceutical solid dose manufacturing, semi-solid, liquid solution and suspensions experience and experience with manufacturing per-approval products.</li><li>10+ years of leadership experience in a manufacturing environment with a demonstrated history of progressive growth and advancement in operations management, or an equivalent combination of education and experience.</li><li>Extensive experience managing FDA, DEA and other regulatory audits, demonstrating a strong understanding of compliance requirements and operational standards.&nbsp;</li><li>Proven track record of successfully leading and managing large operational teams (10 to 200 employees) in a complex manufacturing environment, demonstrating consistent achievement of operational targets and efficiency gains.</li><li>Demonstrated expertise in implementing Lean manufacturing principles and driving continuous improvement initiatives, resulting in measurable improvements in productivity, cost reduction, and quality.</li><li>Bilingual in Spanish, preferred.</li><li>In-depth knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA, DEA).</li><li>Proven track record of career advancement, including Supervisory experience and leadership roles with increasing responsibilities.</li><li>Exceptional leadership and coaching capabilities with a demonstrated ability to build and develop high performing teams.</li><li>Able to build rapport at all levels of the organization and foster a culture of collaboration across diverse teams.</li><li>Able to multi-task, organizational skills and strong relationship management skills.&nbsp;</li><li>Self-starter and able to work in an entrepreneurial environment.</li><li>Effective communication skills, both written and verbal, with the ability to present complex information clearly and concisely to diverse audiences, including senior leadership, clients and regulatory agencies.</li><li>Excellent problem-solving/facilitation skills, with the ability to present complex issues and develop innovative solutions.</li><li>Lean manufacturing background and training preferred.</li><li>Commitment to fostering an inclusive and diverse workplace environment.&nbsp;</li></ul></div></div>\n",
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