|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 company.|
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.
The Manager, Quality Assurance is responsible for managing all aspects of quality and the quality team at the Trigen Laboratories, LLC, Tampa, FL location. Lead the Trigen team in meeting all of the company quality: goals, requirements and expectations.
Duties and Responsibilities
- Coordinate and manage all quality assurance activities within our highly regulated industry to ensure that Trigen objectives are achieved in compliance with federal, state (Florida in particular) and company requirements.
- Manage the implementation, development and monitoring of all documents and activities supporting the quality systems at Trigen and its contract manufacturers/packagers where applicable.
- Provide oversight of regulatory/standards requirements for areas such as Food and Drug Administration (FDA) regulations for finished drugs (i.e. 21 CFR 211), Dietary supplements (21 CFR 111), as well as Florida DBPR requirements.
- On-site quality contact for audits, inspections by 3rd parties (federal, state, etc.).
- Required to initiate reports and documents (i.e. Adverse Event investigations, complaint responses, Field Alerts, Recalls, etc.) that may be submitted to regulatory bodies.
- Oversee the incoming inspection of finished goods.
- Manage the local product complaint process, quality document retention, oversight of warehouse environmental monitoring (i.e. temperature mapping/monitoring, pest control program).
- Review/approval of manufacturers master batch records, label and component specifications.
- Provide annual GMP training for local employees, ensure adequate training for self and direct reports.
- Assist Quality Director with projects as assigned and necessary.
- Bachelor’s Degree in a scientific discipline.
- Minimum 6 years of experience as a quality professional in a pharmaceutical or highly regulated environment.
- Experience with finished goods receipt, and distribution of pharmaceuticals and dietary supplements .
- Extensive knowledge of, and ability to establish or direct the management of, quality systems and quality documentation
- Previous supervisory experience preferred.
- Demonstrated ability to identify issues, drive investigations to root cause and to implement solutions.
- Excellent verbal, written, computer, and technical communication and presentation skills.
- Proven ability to build positive, collaborative relationships with different levels of the organization and clients, customers and providers (i.e. CMO, CPO, 3PL, etc.).
- Ability to effectively manage multiple priorities and deliverables within an entrepreneurial work setting. Ability to prioritize, and schedule work to meet personal and organizational deadlines. Knowledge and experience of when to escalate issues.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.
Keywords: QA, Quality Assurance, Pharmaceutical Manufacturing, Distribution, QA Manager