Senior Director, Operations

Senior Director Of Manufacturing OperationsLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Summary of Objective:The Senior Director of Manufacturing Operations for our Bedford and Manchester sites is responsible for the manufacturing of aseptic and non-aseptic pharmaceuticals and medical devices in accordance with the most stringent quality, regulatory and safety standards. The Senior Director provides support to manufacturing managers, supervisors and associates and strives for excellence and continuous improvement to further enhance the sites' performance and client satisfaction. In conjunction with the Site General Manager, provides direction as well as develops and implements medium- and long-term plans.Essential Duties and Responsibilities:Acts as a technical expert and an escalation point for complex/high impact manufacturing issues/decisionsOversees daily manufacturing of pharmaceuticals and medical devices at the Commerce and Sundial facilities, in compliance with all corporate and regulatory requirementsResponsible for maintaining cGMP compliance and accuracy of all documentation related to manufacturing.Ensures that all departments operate in accordance with department SOPs which meet regulatory and cGMP standardsInstill a strong culture of Lean and Continuous Improvement through the use of the site maturity index.Implements changes to procedures and documentation to ensure all regulatory requirements are being metResponsible for management of production operations in accordance with all relevant health, Safety and Environmental legislationEnsures safety policies and procedures are adhered to at all times. Recommends safety improvements, as necessaryParticipates in regulatory inspections and client quality auditsDemonstrates substantial knowledge of industry best practices and trends of aseptic and/or medical device manufacturing practicesIdentifies root causes of production problems and recommends improvements while working within cGMP regulatory requirementLeads or participates on Project (client and internal) teams to represent the Operations organizationAccountable for identification of gaps, remediation and developing action plans for the implementation of systems to meet short- and long-term manufacturing goalsMakes key decisions and formulates policies that impact strategic objectives of the departmentProvides leadership and guidance to direct reports and project team members to develop strong leaders and support the vision of the organizationLeads Operations personnel, including organizing and prioritizing group tasksWrites performance reviews and oversees team development and communication by providing training, development opportunities and guidance to staffWorks with direct reports to ensure adequate staffing levels are maintainedOther tasks as assigned by managementWork Environment:Works closely with internal operation teamsInteracts with all departmental staff and other departments at all levelsMust be comfortable presenting technical and complex issues clearly to all levels of management as well as client representativesManagement of 5 or more direct reports across multiple sites, some will have managerial responsibilityQualifications:10+ years direct management experience with demonstrated leadership, team management and coaching skills. Demonstration of increasing responsibilities.10+ years of experience in cGMP pharmaceutical and/or medical device manufacturing, experience in both is preferredPrior experience and knowledge of a CDMO or dealing with CDMOs strongly preferredExtensive knowledge in aseptic fill/finish preferredPrevious experience with lyophilized products preferredWorking knowledge of FDA, ICH and EU pharmaceutical and/or medical device requirements, experience with both preferredB.S. in Science, Chemistry or Engineering requiredExcellent written and verbal, and interpersonal communication skillsAbility to work in a fast-paced environment and handle multiple tasks simultaneouslyThe ability to develop solutions to complex problems, which require a high degree of ingenuity, reactivity and innovativenessAbility to lead others in a dynamic, fast paced work environmentHonesty, integrity, respect and courtesy with all colleaguesCreative with the ability to work with minimal supervision and balanced with independent thinkingResilient through operational and organizational changeJoin us and be part of building the bridge between life changing therapies and patients. Let's talk futureEqual Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.