The Compliance Auditor manages both the internal and external audit programs, maintains a Supplier Quality Management program, and serves on the host team during inspections of the Marietta facility. Responsible for implementing inspection readiness programs and driving responses to audits. The Compliance Auditor defines and implements procedures to assure that vendors and outside services contracted to assist in the manufacture and packaging of commercial and/or clinical products comply with internal and US/international standards and guidelines. Audits may include internal/external GxP (excipient/API/component suppliers, contract laboratories, contract manufacturers and CRO’s) and due diligence audits.
Duties and Responsibilities
Plan, perform and document GxP compliance audits to assess compliance with US/international regulatory rules and guidelines, and Osmotica standards at company sites, contractors and vendors.
Regular GxP audits (routine and risk-based).
Define procedure for the conduct of audits; coordinate with internal departments to determine appropriate focus of audits for external vendors.
Coordinate with vendors and contractors to conduct audits and evaluate compliance status.
Advise, guide and support sites in overall regulatory inspection management (PAI / general GMP) covering inspection preparations, execution of regulatory inspections, preparation of responses and inspection follow-up.
Participate in enhancing and maintaining a company-wide platform for sharing of Regulatory Inspection Deficiencies and "lessons learned".
Create and maintain reports of audit activities to communicate findings, for future internal reference, and as a benchmark for further compliance investigations.
Communicate compliance concerns in all areas audited with internal and external management groups to ensure that non-compliant conditions noted during audits are addressed to Osmotica’s satisfaction.
Define process for implementing and evaluating potential corrective actions.
Maintain a Supplier Quality Management program.
Assist with the development and maintenance of Quality Agreements.
Represent Osmotica’s position and policies for regulatory compliance to vendors and contractors.
Maintain knowledge of current regulatory requirements pertaining to clinical trial and drug product manufacture.
Interpret and apply FDA regulations and comparable international regulations, SOPs, and other company policies and procedures on regulatory compliance.
Perform additional duties and responsibilities as assigned.
Ability to work independently, interpret and assess technical documents, communicate and interact effectively across multiple organizational levels.
Skilled at organizing information into a clear, concise written form which fosters adherence to current GxP compliance.
Ability to organize and adapt to organization priority changes and work effectively with minimal supervision with a sense of urgency.
Willingness and ability to travel both domestically and internationally (~ 40% of the time). Ability to get a VISA.
A high level of proficiency in Microsoft Office applications required.
Experience and Qualifications
Bachelor’s degree in Life or Physical Science or related science from an accredited college or university with 10 years experience in pharmaceutical or biotech GMP manufacturing required.
Knowledge of pharmaceutical production, clinical trial management, and application of cGxP regulations in manufacturing of commercial, clinical, and developmental products; ability to interpret guidelines and regulations as applied to manufacturing of multiple products and product attributes; knowledge of manufacturing and packaging equipment and equipment used to verify product quality.
5 Years of experience as a GMP auditor; CQA, CQM, and/or CQE Certification is a plus.
3 Years of experience in regulatory inspections management.
Previous experience assisting with or hosting regulatory agencies inspections.
GLP, GCP audit experience is a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). There are no lifting requirements; however, travel is expected so the general transport of a laptop and personal luggage will take place. No Personal Protective equipment required, unless entering production areas.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform. In February 2016, Osmotica Pharmaceutical combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics co...mpany.
Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies niche over the counter and prescription pharmaceutical preparations, specializing in women's health and pain management with brands such as Divigel®, OB Complete®, Lorzone®, & ConZip®.
Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.