The Vice President of GMP Operations will provide hands-on leadership and management for company-wide manufacturing operations under GTP and GMP environments.. TissueTech, Inc. is the leader in innovative technologies using products derived from human amniotic and umbilical cord tissues. Since its inception in 1997, the Company has pioneered the clinical application of human placental tissues - more than 300,000 patients have been treated with TissueTech products and the Company's groundbreaking scientific and clinical achievements have been documented in more than 300 peer-reviewed publications.. TissueTech, Inc. does not sponsor applicants for work visas. All applicants must be legally authorized to work in the US.. This position is not open to unsolicited resumes from recruiters and is not eligible for relocation assistance.. POSITION SUMMARY:. The Vice President of GMP Operations will provide hands-on leadership and management for company-wide manufacturing operations under GTP and GMP environments. Specifically, this individual will plan, organize and direct the activities of GMP/GTP manufacturing operations including tissue and biologics product processing, equipment placing and maintaining, production schedule and inventory planning, processing improvements and validation, supply chain/materials management, storage of inventories, and distribution/fulfillment of released products. The GMP/GTP operations will include products that are manufactured internally as well as by outside contract manufacturers. This position will work closely with the Quality Assurance team and the Finance, IT teams and also be a resource to commercial and research & development teams and provide support to customer services.. Manage the Company's entire GMP/GTP production and distribution operations described above effectively and efficiently to maximize the ROIs of human and financial resources while in compliance with current Good Manufacturing Practice (cGMP) and other applicable regulations.. Supervise daily manufacturing operations at different locations, develop operating plans and project milestones and set performance goals for each operational function unit.. Supervise the execution of required validation/verification activities occurred in production, including validation of process flow changes and improvements.. Effectively and efficiently use the ERP system or other systems to plan for production schedules, enhance inventory management, and distribution.. Design the organizational structure, recruit adequate personnel and design adequate training programs.. Review and implement the Standard Operational Procedures in compliance with the regulatory requirements.. Cooperate with the Quality Assurance team in investigating, reporting, monitoring operational deviations and errors that trigger non-conformance and subsequent corrective and preventive actions.. Develop and Manage financial budgets - including operational and capital.. Any other duties as assigned.. POSITION EXPERTISE/QUALIFICATIONS:. Education - Bachelor's Degree in a life science field, preferably in a bio-medical discipline.. Experience - 20+ years of experience in GMP Operational environment in the industry of life science, human tissue/cell based bio-pharmaceuticals and/or regenerative medicine with P&L responsibilities.. Thorough understanding of tissue and biologics cGMPs, quality systems and compliance requirements.. Demonstrated good analytical quality in the decision making process.. Self-motivated and flexible with the ability to hands-on solve problems effectively in a dynamic, fast growing environment.. Ability to address obstacles with energy and determination and exhibit commitment to change and passion for best interests.. Strong leadership skills to engage, influence and motivate colleagues as well as subordinates in the organization.. The ability to independently solve problems and define strategic direction and initiatives in response to internal and external stimuli.. Glassdoor has millions of jobs plus salary information, company reviews, and interview questions from people on the inside making it easy to find a job that's right for you.
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