Selkirk Pharma is looking for a Director of Quality Assurance Validation to develop a validation program at an aseptic fill finish Contract Manufacturing Organization (CMO) that is currently under design. The position will provide a unique opportunity to develop a department and systems with the Selkirk Pharma team. Initially, the selected candidate will establish a plan and drive a team to execute commissioning and qualification activities to meet regulatory and industry standards for US and European markets. The new facility will rely heavily on technology, making data integrity and computer system validation necessary focuses for the successful launch into commercial production activities. Long term, the validation group will support ongoing qualification efforts and oversee client process qualification activities. This position requires leadership over the validation group and the successful candidate must be ethical, principled, knowledgeable and adaptable to ensure the team is dedicated to the same expectations.
The facility will employ isolators located in an ISO8 (Grade C) background to provide an ISO5 (Grade A) environment for aseptic filling. Support infrastructure will include air handling equipment, preparative autoclaves, terminal sterilization autoclaves, WFI systems, parts washers, card access systems, electronic batch records (eBR), electronic Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Building Automation System (BAS), Supervisory Control and Data Acquisition (SCADA), Enterprise Resource Planning (ERP), compressed air, and compressed nitrogen. Full analytical, microbiological, metrology, engineering and maintenance functions will be supported onsite by internal departments.
Working with other departments, build a team capable of handling equipment, software, and process qualification. The team will be collaborative internally (team and facility) and externally (clients, consultants and vendors) with a culture of quality, efficiency, and continued intellectual growth.
Oversee the commissioning and qualification (initial and continued) of equipment and facilities to meet US and EU regulatory requirements in an aseptic fill finish CMO.
Staff and oversee a group of employees responsible for developing and executing process validation documentation for client owned processes.
Remain up to date on industry validation practices, trends, and regulations while freely disseminating information to colleagues and employees.
As a member of the quality unit, the Director of Quality Assurance Validation may be required to participate ad hoc as a quality unit representative.
Interact with clients and regulatory authorities in audits and discussions supporting the facility, manufacture of client owned products and commercialization of client owned products.
Bachelors degree in Engineering or other related scientific discipline with a minimum of ten (10) years of pharmaceutical industry experience. Minimum of five (5) years of experience supervising or managing equipment qualification and/or process validation activities and personnel.
Project management experience.
Knowledge of FDA cGMP, GAMP 5, 21CFR Part 11, Eudralex Volume 4 Annex 1, ASTM E2500, ICH, ISPE and other industry related guidance documents.
Experience participating in regulatory agency audits (FDA, EMA, ANVISA, PMDA, etc).
Demonstrable diversity in project experience is of advantage to the candidate.
Selkirk Pharma invites employees to participate in a comprehensive benefits package that includes medical, dental, vision, life AD&D, FSA for health and dependent care and retirement plans.
About Selkirk Pharma
We were founded by a team of physicians and pharmaceutical industry experts, with the sole focus of providing a more reliable supply of medication to healthcare providers and the patients they serve. We are grateful for the opportunity to work in healthcare, and we come to work every day knowing that patients are counting on us to make medicines that allow them to live fuller, healthier lives.
Our new 80,000 sq ft facility is being constructed in Spokane WA, specifically designed for aseptic fill finish CMO operations. Filling equipment will be housed in isolators and other technology is similarly being evaluated with a forward look to the longevity of compliance.