Sr Manager, QA Document Control & Training

Seaport Therapeutics is seeking an experienced Sr Manager, QA Document Control & Training to manage document control and training activities to support GxP operations and maintain compliance with health authority regulations and established Seaport standards. This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 3 – 4 days per week to foster collaboration and effective leadership as the Quality function is established. The role will report to the VP, Head of Quality.

Seaport Therapeutics has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass liver metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com

Summary of Key Responsibilities

· Lead day-to-day Document Control activities including creating, revising, reviewing, tracking and releasing Standard Operating Procedures (SOP), Forms, Templates, and Work Instructions (WI), and other controlled documents, in a timely manner while ensuring compliance with all Quality, Regulatory and company standards.

· Establish and maintain records management system including secure storage, retrieval, retention and destruction.

· Serve as point-person/system admin for the company's electronic Document Management Systems (eDMS). Participate in the implementation and periodic maintenance and upgrades to the eDMS, including creating/revising procedures and performing validation activities.

· Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.

· Identify and implement document control process improvements to ensure compliance with internal and regulatory requirements.

· Provide support during regulatory/client inspections as well as internal audits.

· Execute GxP Training strategy – including working with stakeholders to determine learning needs and priorities and provides appropriate training to meet those learning needs.

· Evaluate training needs and participate in the development and delivery of training materials, including but not limited to Quality and GxP functions as needed, utilizing high-quality, innovative, timely, and effective learning solutions.

· Develop training materials (ex: eLearnings, Instructor-led), in collaboration with SMEs, for existing employees ensuring all aspects of job responsibilities and expectations are met to improve efficiency, effectiveness and compliance and address gaps appropriately.

· Manage projects and training initiatives which directly support GxP initiatives, to effectively implement strategic business objectives in driving quality, compliance and safety.

 

Qualifications

· Bachelor's degree in Science or related field

· 6-8 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function

· Strong knowledge of GxP and regulatory requirements

· Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment

· Motivated by patient focus and personal commitment to high performance and results

· Possesses high integrity and exceptional work ethic

This is a hybrid role with 3-4 days onsite in our office in the Seaport of Boston