Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
The Senior Director of Quality Control (QC) will be responsible for leading the Quality Control Unit at Ocular Therapeutix (OTX) as the Organization continues growing and expanding its clinical and commercial capabilities. The ideal candidate shall demonstrate solid leadership and communication skills in a critical and dynamic role that will be broadly engaged across OTX operations. The incumbent will be responsible for leading the development, planning, implementation, and maintenance of QC activities, which include Analytical Methods, processes, and routine operations for new or existing products and/or technologies at OTX, ensuring that the QC practices remain in compliance with the relevant industry standards and applicable regulations.
The QC Unit is comprised of the following functions: Commercial/Clinical Release Testing, Microbiology, Environmental Monitoring, QC Systems and Equipment, Stability, Raw Materials, and Analytical Development. This is a people management role which will require from the candidate the ability and skills to manage staff, including supervising routine activities, managing performance, mentoring staff members as well as creating and supporting development plans. The position will be reporting to the Vice President, Global Head QA/QC at OTX and is expected to be onsite.
Primary Duties and Responsibilities:
Provide leadership for the OTX QC Unit through development and implementation of the overall Quality Strategic Plan and the established goals. Leading the development, validation, planning, implementation, and maintenance of QC test methods, processes, equipment, systems, and operations applicable to the lifecycle stage of the product. Hiring and onboarding QC personnel based on the needs of the operations. Leading the development and/or maintenance of Policies, Standard Operating Procedures (SOPs), and Test Methods required for the operations of the QC Unit. Leading the implementation of applicable electronic Data Management Systems (i.e., LIMS). Supporting data management, trending, and data integrity analysis/investigations. Supporting the management of laboratory investigations, Out-of-Specifications (OOS) and Out-of-Trending (OOT) results as well as Change Controls and any other quality record (i.e., Corrective/Preventive Actions) associated with QC operations. Overseeing the management of Contract Testing Laboratories as part of the Vendors Management Program and ensuring activities are conducted according to the established Quality Agreements. Participating as a key member of cross-functional teams and ensuring QC resources are available to support critical projects to meet the defined goals and timelines. Collaborating in the compilation of data and reports in support of regulatory submissions, Quality Management Reviews (QMRs), internal/external audits, and Annual Product Quality Reviews (APQRs) for commercial products. Acting as the Subject Matter Expert (SME) during Regulatory Inspections and observations responses. Assessing and enhancing the QC programs (i.e., Stability, Sample Management, Training) and identifying opportunities as part of the continuous improvement initiatives aimed at adding efficiency to the QC operations and the production cycle time. Maintaining the QC Unit in a state of compliance and inspection readiness. Leading, mentoring, and developing staff members and promoting a Quality Culture within QC and across OTX. Other responsibilities associated with this role may apply as applicable.
Qualification Requirements:
Technical Qualifications:
Sc./M.S. in Life Sciences or Engineering discipline with a minimum of 15 years of experience in a QC operation, preferably in a pharmaceutical setting. In-depth knowledge of FDA/EMA/ICH regulations and guidelines. Experience participating in internal and external audits as the area SME. Experience in management of Reference Standards, Sample Management, Data Management, and Stability Programs. Experience drafting and processing protocols, reports, and compliance documents. Experience in data compilation and analysis. Experience in Environmental Monitoring techniques. Knowledgeable in the application of Operational Excellence tools and continuous improvement initiatives.
Leadership Qualifications:
At least 8 years of managerial experience. Solid organizational, staff mentoring, and time management skills with excellent attention to details and experience with risk-based decision-making models. Proven ability to negotiate, influence, and work in cross-functional settings. Handling multiple assignments in a fast-paced and dynamic environment and ability to prioritize accordingly. Independent development and execution of plans with minimal supervision. Strong analytical problem solving and critical thinking skills. Excellent technical writing and communication skills.Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.