Atlanta, GA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Operations / Production
Job Description:62 people have viewed this job
Based at our corporate office in the Atlanta area The VP of Operations will lead and manage all Alimera Sciences manufacturing operations, including product supply chain, quality, and contract manufacturing organizations (CMOs).
This person will provide leadership and strategy to ensure consistent product supply and inventory in support of sales, employing best practices to continually improve quality, operational efficiency, and product cost.
They will closely coordinate activities with Regulatory Affairs to ensure the ability to supply Alimera Sciences products globally as well as, identify opportunities for improvement throughout the supply chain (i.e., from component manufacture through commercial operations) and provide systematic leadership to grow operational capabilities and product sales.
Essential Duties and Responsibilities
Provide leadership overseeing the manufacture of all Alimera Sciences products globally, ensuring delivery, quality, and cost requirements are met
▪ Establish and support the management of a global Sales and Operations Planning process
▪ Establish and support the management of a global Quality Management System (QMS)
▪ Lead the management of CMO sites to ensure that all GMP and Inventory requirements for the Alimera Sciences products are met
▪ Work closely with Quality and Regulatory Affairs internally and at CMO sites to ensure the ongoing effectiveness of product manufacturing and ability to supply globally
▪ Identify and implement opportunities for improving delivery consistency, cost-effectiveness of the operational processes, and meeting all applicable global quality standards
Coordinate timelines and deliverables for all Operations and Quality projects
▪ Manage process and testing improvements and QMS enhancements
▪ Manage the technology or manufacturing transfer of products, assuring they are manufactured to specifications and costs
▪ Actively participate in all QMS review and improvement activities; advocate for quality in all aspects of manufacturing and customer support
▪ Coordinate with Quality the review and audit of vendors
▪ Manage external resources, including onboarding of CMOs and the use of consultants or paid advisors
Identify opportunities to support commercial operations and drive systematic improvement in conjunction with Sales and Marketing management.
Education and Work Experience
▪ BS/MS in biological sciences or chemistry with minimum 15 years’ work experience.
▪ Minimum of 10 years of experience in pharmaceutical manufacturing, quality, and development roles.
▪ A minimum of five years’ experience in medical device development and manufacturing.
▪ Experience of managing global teams as direct reports, indirect reports and/or third parties.
Specialized Knowledge and Skills
▪ Global experience with demonstrated ability to manage cross-cultural differences.
▪ Experience in leading or being part of a team through the successful approval of a new drug in the US and Europe.
▪ Experience in leading meetings, teams, CMOs.
▪ Demonstrated management experience including employee development and leadership.
▪ In-depth experience with issues related to pharmaceutical and medical device manufacturing.
▪ Involvement in regulatory interactions / filings involving pharmaceuticals as well as combination products (drug/device).
▪ Knowledge of current requirements for cGXP.
▪ Forward-thinking and creative with high ethical standards.
▪ Team player with leadership skills with ability to influence others to achieve successful results.
▪ Strong interpersonal skills with an ability to communicate to people at all levels of an organization.
▪ Professional credentials which might include: Six Sigma or Process Excellence.