Careers

Our success depends upon highly-talented, team-oriented people who are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families impacted by disorders of brain development. If you share a passion for our mission, and you’re interested in further exploring employment at Seaside, we are recruiting for a variety of Regulatory and Quality Assurance positions, as described below.

Experienced candidates are encouraged to submit a resume and cover letter to careers@seasidetherapeutics.com

Senior Document Control Associate
Position Summary:
Reporting to the Senior Director, Regulatory and Quality Affairs, this detail-oriented, self-starter  will create and execute document and change control policies and procedures that comply with FDA and other related requirements, as well as drive compliance with these policies and procedures.

Responsibilities:

  • Manage and maintain electronic and manual Document Storage Files and all contained documents/binders.
  • Facilitate the drafting, review, revision, approval and distribution of controlled documents.
  • Facilitate the periodic review process of SOPs and work instructions (WIs).
  • Finalize and archive documents (study documents, regulatory submissions, SOPs, WIs, Forms, and Templates).
  • Perform other related duties as assigned.

Requirements:

  • BA or BS degree in Life Science, quality assurance, or a related field.
  • A minimum of three years of experience in document management role, preferably in the medical device or pharmaceutical industry.
  • Excellent proofreading, editing, and technical writing skills.
  • Strong time management and organization skills, as well as a high level of detail orientation.           
  • Computer savvy in the full Microsoft Office Suite including Word, Access, Excel, and Outlook.  Adobe Acrobat experience preferred.
  • Strong communication and interpersonal skills to build solid internal customer relationships.

 

Associate Director, Regulatory Affairs
Position Summary:
Reporting to the VP, Regulatory and Quality Affairs, this experienced professional will support regulatory strategies and filings for our development stage activities, including participation on internal drug development teams, support of labeling activities, and interaction with key regulatory authorities.

Responsibilities:

  • Applies global regulatory guidelines and requirements, developing optimal regulatory strategies and providing strategic insights that effectively translate regulatory requirements into practical, workable registration plans.
  • Provides hands-on management of assigned regulatory filings, including U.S. IND and NDA submissions; supports any international dossiers in conjunction with our Alliance partners including European MAAs and Canadian NDS submissions.
  • Ensures timely completion of assigned submissions required for maintenance of INDs, NDAs, and possible CTAs, such as adverse event reports and annual reports.
  • Further designs, implements, and expands regulatory processes and procedures to ensure  high quality and timely submissions, as well as compliance with regulatory requirements.
  • Prepares scientifically valid internal regulatory records in helping to ensure that Seaside is “inspection ready” at all times.
  • Contributes to Seaside’s ongoing initiatives to develop an efficient and effective regulatory support infrastructure, and the further implementation of standardized processes and procedures.
  • Works collaboratively with all cross-functional leaders, including Quality Assurance, Clinical Development and Clinical Operations to actively monitor company activities and facilitate compliance with global regulatory standards and requirements.
  • Effectively supports manufacturing and business development teams to ensure achievement of corporate goals and timelines.

Requirements: 

  • BS in related field and Master’s Degree preferred.
  • A minimum of five years directly related regulatory affairs experience in biotech or pharma.
  • Solid regulatory filing background in either drugs or biologics, ideally including post-market experience.
  • Comprehensive knowledge of current global health authority regulations and guidelines, with experience in the preparation of IND and NDA submissions for drug products; previous experience with labeling/promotion, and prior interactions with the Office of Prescription Drug Promotion is preferred.
  • Demonstrated ability to work collaboratively and independently; ability to effectively build productive cross-functional collaborations.

 

Quality Assurance Associate
Position Summary:
Reporting to the Senior Director, Regulatory and Quality Affairs, the Quality Assurance Associate will perform hands-on, quality-related duties to assist in the implementation and maintenance of a compliant Quality System.

Responsibilities:

  • Review GMP documents, including:
  • Specifications
  • Analytical methods
  • Batch records
  • CMO Certificates of Analysis/Certificates of Conformance
  • Stability protocols and reports
  • Audit reports 

Establish and/or maintain compliant Quality Systems, including:

  • Standard Operation Procedures
  • Vendor Qualification
  • Change Control
  • Document Control
  • CAPA
  • Deviations and Investigations
  • Complaint Handling
  • Annual Product Review
  • Internal Audits 

Requirements:

  • B.S. degree in a related field, with at least two years of quality assurance experience in the pharmaceutical, biotechnology or medical device industry. Previous experience auditing supplier products and/or services, auditing clinical sites, and/or in the review and trending of stability is preferred
  • Knowledge of quality concepts and quality systems 
  • Understanding of manufacturing processes and operations
  • Strong technical, interpersonal, problem-solving and decision-making skills
  • Quality Auditor Certification or the desire to obtain certification preferred

 

Quality Assurance Manager – Clinical Compliance
Position Summary:
Reporting to the Senior Director, Regulatory and Quality Affairs, this seasoned professional  will maintain the Quality Systems and infrastructure appropriate for product development in compliance with Good Clinical Practice (GCP) requirements. This organized, self-starter will  manage quality requirements for the conduct of clinical trials, ensuring the realization of industry best practices for GCP activities while remaining adaptable to the changing needs of development programs.

Responsibilities:

  • Provide ad-hoc, QA-related expertise in partnering with internal customers cross-functionally to effectively manage clinical trials. Collaboratively address and resolve related challenges and issues. 
  • Assist in the development of Quality Agreements with GCP vendors.
  • Develop audit schedules and manage and/or conduct global GCP audits.
  • Prepare and/or review written reports for audits and inspections.
  • Oversee and/or conduct CQA review of clinical protocols and reports.
  • Develop and implement QA processes and process improvements.
  • Manage and oversee audit responses and closeout of associated CAPAs.
  • Coordinate GCP-related inspections by regulatory authorities.
  • Develop and maintain tracking reports, scorecards, and other tools to monitor Quality System performance.
  • Develop and deliver GCP training programs or revisions to training curricula.
  • Maintain relationships with vendors, contractors, and consultants to ensure effective execution of assigned tasks.
  • Promote GxP and quality mindset at all levels within the organization.

Requirements:

  • Bachelor’s degree in related field and at least 6 years of Clinical QA experience supporting clinical trials in the biologics, pharmaceutical, or medical device industry, with  3-5 years  experience conducting and managing GCP quality assurance audits and CAPA closeout.
  • Deep knowledge of the clinical trial process (Phase I-IV).
  • Ability to effectively lead projects with minimal supervision.
  • Ability to anticipate and flexibly adjust to rapidly changing priorities.
  • Strong communication and relationship-building skills. Solid problem-solving skills with demonstrated ability to exercise sound judgment.

 

Quality Assurance Manager – GMP Compliance
Position Summary:
Reporting to the Senior Director, Regulatory and Quality Affairs, this seasoned professional will maintain the Quality Systems and infrastructure appropriate for product development in compliance with Good Manufacturing Practice (GMP) requirements.  This organized, self-starter will ensure the successful and timely release of drug product and clinical trial material by providing quality oversight of the overall manufacturing, testing, packaging and labeling process.

Responsibilities:

  • Develop Quality Agreements with vendors performing GMP activities.
  • Develop audit schedule and manage and/or conduct global GMP audits.  Prepare and/or review audits reports.
  • Oversee and/or conduct review of master and executed drug product and clinical packaging batch records; ensure all raised exceptions are closed prior to product release.
  • Develop and implement QA processes and process improvements.
  • Review stability protocols and reports to ensure continued product stability and appropriate retest dates.
  • Develop and maintain tracking reports, scorecards, and other tools for monitoring the Quality System.
  • Coordinate GMP-related inspections by regulatory authorities.
  • Develop and deliver GMP training programs or revisions to training curricula.
  • Promote GxP and Quality mindset at all levels within the organization.

Requirements:

  • Bachelor’s degree in related field and at least 6 years of QA Compliance experience supporting API and drug product manufacturing in the biologics, pharmaceutical, or medical device industry, including 3-5 years experience conducting and managing GMP quality assurance audits and CAPA closeout.
  • Ability to effectively lead projects with minimal supervision.
  • Ability to anticipate and flexibly adjust to rapidly changing priorities.
  • Strong communication and relationship-building skills. Solid problem-solving skills with demonstrated ability to exercise sound judgment.

 

Experienced candidates are encouraged to submit a resume and cover letter to careers@seasidetherapeutics.com.


Seaside Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, as well as excellent employee benefits. Our location is accessible by public transportation and we provide free, on-site parking.

Note to Employment Agencies: Please do not forward any unsolicited resumes. Seaside Therapeutics is not responsible for any fees related to such resumes.