Sr. Manager, QA Compliance

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to uphold the highest standards in pharmaceutical and medical device products. This critical role involves managing Supplier Quality Management, ensuring compliance with regulatory guidelines, and preparing the site for audits. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in GxP settings, and will demonstrate strong organizational and communication skills. Join a dynamic team where your expertise will drive improvements and enhance quality operations, making a significant impact in the biotechnology and pharmaceutical sectors.

Qualifications

• 10+ years of experience in the pharmaceutical industry required.
• Expertise in vendor management and compliance essential.

Responsibilities

• Manage Supplier Quality Management and ensure compliance with regulatory guidelines.
• Prepare for internal and external audits and manage vendor qualifications.

Skills

Vendor Management

Quality Management Systems (QMS)

Compliance

Organizational Skills

Communication Skills

Attention to Detail

Education

Bachelor’s Degree

Tools

Master Control

MS Office

Job description

Responsible for maintaining quality standards for Ocular’s pharmaceutical and medical device products by managing activities associated with Supplier Quality Management, Document Control, Training, Internal Auditing, and Inspection Readiness.

This is a critical position, and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the Sr. Director of Quality Systems and Compliance.

Principal Duties and Responsibilities include the following:

• Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance.
• Prepare 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.
• Coordinate vendor audits and manage the qualification of vendors supporting Ocular’s GxP operations, including vendor selection and corresponding risk evaluation.
• Collaborate in cross-functional scenarios for the onboarding of vendors, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications).
• Accomplish the objectives and goals of the Quality Organization.
• Manage deviations, change controls, and CAPAs associated with the programs under responsibility, as necessary.
• Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements.
• Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX.
• 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 Master Control.
• Perform additional duties as deemed appropriate.

Qualification Requirements:

• Bachelor’s Degree.
• 10+ years of experience in the pharmaceutical industry.
• Experience working in a GxP setting (commercial and clinical).
• Expertise in vendor management, QMS, and compliance.
• Knowledge of domestic and international regulatory guidelines such as CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others.
• Knowledge of electronic systems, such as Master Control.
• Experience with external regulatory inspections (e.g., FDA).
• Excellent organizational skills and attention to detail.
• Strong interpersonal, verbal and written communication skills.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Biotechnology Research and Pharmaceutical Manufacturing