Job Type: Full-time
Location: Bethesda, MD
Job Title: Senior Manager / Director, Quality Assurance
Company Overview:
Pocket Naloxone Corp. (PNC) is a startup pharmaceutical company based in Bethesda, MD. The
company is currently developing a nasal OTC naloxone asset and has several pipeline
candidates also utilizing the same nasal delivery platform. The company is committed to help
prevent families from losing loved ones needlessly to opioid overdoses by making its flagship
naloxone product widely available at a low price point, after receiving regulatory approval.
Position Overview:
This position is responsible for developing and implementing a quality management system
(QMS) in an organized and efficient manner adhering to Food and Drug Administration (FDA)
policies. Manage audits/inspections to ensure Pocket Naloxone Corp. (PNC) vendors are in
compliance to the FDA and other worldwide health authority regulations /guidelines, site SOPs,
protocols, and industry standards, as applicable. This includes applying developed skills to
assure management that the facilities and buildings, equipment, personnel, organization,
methods, procedures, records, reports, and/or controls are in conformance with applicable
regulations. Ensures all documentation, processes, procedures, and SOPs are compliant with
current industry standards.
Responsibilities:
- Responsible for strategic development of the Quality function and oversight of PNC’s
total quality management system ensuring compliance with all regulatory and
organizational requirements. - Ensures that cGMP, GLP, GCP, and GDP (GxP) requirements and quality standards are
recognized, understood and maintained across the company. - Defines quality objectives, quality assurance systems, agreements, training programs,
and policies for the company and develops the necessary plans and actions to meet the
established objectives. - Ensures the company’s outsourced activities are conducted in compliance with company
procedures as well as FDA, ICH, ISO and other applicable regulatory expectations and/or
requirements. - Ensures products manufactured at CDMOs meet company quality standards and
government regulations through Sponsor Quality review of CDMO records and reports
(i.e., Master Batch Records, Executed Batch Records, Certificates of Analysis (CoAs) and
associated testing, Out of Specification (OOS)/Out of Trend (OOT) investigations. - Collaborates with the clinical, operations, and product development to assure that the
company uses best practices in compliance with applicable regulations with an emphasis
on continuous quality improvement. - Oversight of all key quality systems associated with PNC’s products such as complaints,
change controls, deviations, corrective and preventive actions (CAPAs) and
investigations. - As required, interfaces with regulatory agencies on matters pertaining to processes,
products or Quality systems related to GMP compliance. Provides support during
regulatory inspections and audits. - Provides guidance for recommendations of CAPAs pertaining to quality concerns.
Develops resolution of quality concerns and reviews implementation of CAPAs. - Reviews metrics and trends as well as compliance issues and their resolution on a
periodic basis and works with the GMP functional departments to achieve continuous
process improvement. - Take on other activities as appropriate.
The above statements are intended to describe the general nature of work performed by those
in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Qualifications and Skills:
- Minimum bachelor’s degree ideally in the life sciences.
- Ideally 10+ years industry experience with:
o 8+ years of experience ideally in quality assurance, quality systems, and/or a
compliance role with increasing responsibility in a pharmaceutical or biotech
company. - Hands on leader with experience in implementing GMP processes and procedures in a growing organization. GCP experience desired.
- Extensive knowledge of and in-depth experience with GMP regulations pharmaceutical manufacturing environments for USA, and preferably also for EU and other global health authorities.
- Experience in managing vendor audits.
- Experience with participating in government regulatory audits and inspections.
- Ability to understand, communicate, manage and work with multiple stake holders with different functional expertise.
- Demonstrated strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Ability to be flexible and adaptable in a startup environment and a desire to be part of building the organization’s infrastructure and steering its expansion and growth.
Travel:
Ability to travel as needed.
Other Information and Benefits:
Pocket Naloxone Corp. is an equal opportunity/affirmative action employer. Qualified
applicants will receive consideration for employment without regard to sex, gender identity,
sexual orientation, race, color, religion, national origin, disability, protected veteran status, age,
or any other characteristic protected by law.
Employees are eligible to receive health, vision and dental insurance and participate in the 401k
plan. The Company provides life and short and long-term disability to employees. Full-time
employees receive 21 days of paid time off.
If you are a results-driven and highly motivated individual with a passion for healthcare, we
encourage you to apply!
Send your resume or CV to [email protected]