Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders.

Headquartered in Radnor, PA, we are a hybrid team of dedicated and talented professionals who value innovation, are committed to developing new therapies for patients with rare epilepsy and seizure disorders and are passionate about making a positive impact on our patient and local communities.

We are currently searching for an experienced professional to join our team as a:

QUALITY ASSURANCE MANAGER

Reporting to the Senior Director, GxP Quality Assurance, the Quality Assurance Manager is responsible for management of routine quality assurance activities supporting both clinical and commercial processes in conformance with Good Clinical Practices and current Good Manufacturing Practices requirements. This position will directly support commercial production activities including vendor audit and qualification, deviation management (investigation, resolution, CAPA), training, electronic system administration, support of internal quality system, and other duties. Additionally, this position will support clinical trial activities including, but not limited to, assisting with site audits, managing investigational product, reviewing documentation, and assisting with general compliance. This role will support all aspects of Marinus Quality Compliance (internally and externally) through development and application of quality standards.

Key responsibilities will include:

• Utilize Strong technical writing ability for SOPs, Protocols, Deviations, and other quality related documents
• Manage key vendors through audits, risk assessment, and interaction with quality leadership.
• Build, monitor and report on the compliance status of both the Marinus quality system and the quality systems of key strategic partners
• Write, review, and approve validation documentation including equipment, facility, and process.
• Provide guidance on 21 CFR Part 11 programs and activities
• Apply the concepts of risk management effectively
• Utilize Advanced knowledge of quality management standards and industry guidance on quality systems.
• Lead investigations into out of specification results, deviations, or other non-conformance
• Ensure control of systems, processes and product through review and approval of change control and risk-based implementation.
• Leads investigational review of vendor deviations and work with vendor Quality Assurance to identify resolution quickly and effectively.
• Ensures QA procedures and processes are developed, maintained, adequate, and efficient.
• Ensures team training is performed, adequate and completed.
• Participates in regulatory agency audits and inspections.

QUALIFICATIONS:

• Bachelors degree required, preferably in a core or related science.
• A minimum of 5 years of direct experience working in a GMP environment, preferably in a pharmaceutical environment.
• Minimum of 3 years direct experience performing vendor audits using applicable standards (GxP, ISO).
• Experience with computer system and software validation and 21 CFR Part 11 implementation desired.
• Experience with equipment, facility, process, and other validations
• Strong technical writing ability required
• Experience in pharmaceutical quality operations and drug product manufacturing.
• Must have thorough understanding of appliable regulatory requirements with an emphasis on cGMP and GCP requirements.
• Strong Attention to detail, effective time management and strong organizational skills
• Up to 20 % travel is required based upon business needs

At Marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Marinus Pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.