Role Summary:

The Associate Director, Quality Assurance (QA) Operations role will be the QA technical lead on a selection of external manufacturing and testing project teams and responsible to develop, establish, and maintain Quality Systems, Procedures, Policies and Metrics that support those external manufacturing activities in conjunction with the Director of QA Operations. This role will provide leadership for applicable quality operation activities and proactively assess compliance issues and risks serving as an expert GMP consultant for issue management & issue escalation, with a focus on critical and major quality events. The Associate Director QA Operations role will participate in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality operations.

This role will work closely with key stakeholders including CMC, Regulatory Affairs, and Project Management.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate.

Primary Responsibilities Include:

• Oversee release activities for Drug Substance Intermediates (DSI) including batch record review/release activities

• Represent Dyne QA Operations at CMO meetings

• Ensure that contract manufacturing activities are aligned with current regulatory requirements, standards, and industry trends

• Work within and improve the internal framework for the review of batch records and ensure that any compliance issues are addressed in a timely manner

• Manage CMO documentation and files for internal access

• Lead or support CMC investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness

• Participate in CMO Quality Agreement review

• Support change management actions that directly impact manufacturing and/or testing

• Provide input for DSI specifications, stability protocols, and product labeling as needed

• Participate in domestic and international audits of CMO sites

• Support on-site internal auditing program by assisting with audits when required

• Develop and monitor metrics (KPIs) for Quality Operations for Management Review

• Provide QA operations training to teammates

• Support investigational new drug applications and related correspondence from global regulatory authorities

Education and Skills Requirements:

• Bachelor’s degree/master’s degree in engineering, Science, or relevant discipline

• Minimum of 8 years’ experience in related cGMP environment (Bioconjugate manufacturing preferred)

• Minimum of 5 years of related work experience in Quality Assurance or closely related role within Biopharmaceutical regulated industry, preferably with experience overseeing CMO/CDMO organizations

• Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations

• A proven track record of demonstrating good judgement & decision-making experience

• Excellent organizational skills

• Ability to concisely present quality events and the criticality to internal stakeholders

• Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues

• Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA

• A working knowledge of the muscle disease therapeutic industry would be beneficial

• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources to deliver consistently

• Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods

• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet to all QA activities when required

• Proficiency with software applications such as MS Office, Smartsheet, Veeva a plus

• Up to 15% travel

LI-Onsite $50,000 — $75,000/year