Senior Associate, Quality Assurance

This role is responsible for maintaining Quality standards for Ocular's pharmaceutical and medical device products by managing activities associated with Quality Risk Management (QRM), Internal Auditing, and Inspection Readiness. The ideal candidate will have familiarity with and some experience in all of the responsibilities listed below but may focus on a subset of them for their core work depending on the background and experience of the candidate. The Senior Associate, Quality Compliance is responsible for the maintenance of the QRM program within Ocular Therapeutix. This role ensures that quality risk assessment, mitigation, and control strategies are robust, compliant with ICH Q9(R1) guidelines, and integrated into the Quality Management System (QMS). In addition, this person will be responsible for assisting with the execution of the Internal Auditing and Inspection Readiness programs, ensuring that all GxP groups are regularly examined for compliance gaps and are maintained in a constant state of inspection readiness. This role will require an onsite presence due to the level of cross-functional collaboration involved. This role is based onsite due to the level of cross-functional collaboration involved., Maintain the following areas in collaboration with other team members to drive improvements and achieve adherence with regulatory expectations: Risk Management, Internal Audits, Inspection Readiness, and general Quality Compliance.

• Inspection Readiness and Internal Auditing: Assist in preparing the site for the success of internal and external audits ensuring that all the processes and systems remain aligned and in compliance with the applicable regulatory guidelines and industry standards. Execute internal audits as necessary.
• Risk Management: Assist in identifying, assessing, and mitigating risks related to Ocular drug development, manufacturing, safety, regulatory compliance, and market access, focusing on ICH Q9 and using tools like FMEA to ensure patient safety, regulatory adherence, and business continuity. Facilitate risk assessments and foster a proactive, risk-based culture to ensure patient safety and product quality throughout the product lifecycle in compliance with Quality Risk Management regulations, guidances and standards.
• Additional Responsibilities:

• Manage deviations, change controls, and CAPAs associated with the programs under responsibility, as
• Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements, and revise as necessary.
• Be familiar and comfortable working in other areas of Quality Compliance, specifically Supplier Qualification and Training.
• Identify opportunities for improvement and implement necessary actions to optimize the processes/systems and add efficiency to the Quality operations.
• Participate in the implementation of new electronic systems, such as MasterControl, as necessary.
• Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX.
• Accomplish the objectives and goals of the Quality Organization.
• Perform additional duties as deemed appropriate.

Do you have experience in Team training?, Do you have a Bachelor's degree?, * Bachelor's degree is required.

• 5+ years of experience in the pharmaceutical industry is required.
• Experience working in a GxP setting (commercial and clinical) is required.
• Expertise in Risk Management, Inspection Readiness, Supplier Management, Training, and general Quality Compliance is required.
• Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others are essential.
• Knowledge of electronic systems, such as MasterControl is highly preferred.
• Experience with external regulatory inspections (e.g., FDA) is highly preferred.
• Excellent organizational skills, attention to detail, as well as strong interpersonal, verbal and written communication are essential.
• Computer literacy, including proficiency in MS Office, Excel and PowerPoint is required.

3.83.8 out of 5 stars 15 Crosby Dr, Bedford, MA 01730 $109,000 - $121,000 a year

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.