Director of Quality Assurance – Southeast

The Director of Quality Assurance will develop and deploy the quality system for manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company policies and procedures. The incumbent will manage the Quality Organization in support of business and Company initiatives.  The successful candidate will interface with Production, Regulatory Affairs, Marketing, New Product Development and other departments to maintain awareness of Quality activities.  The incumbent will understand and deploy processes to assure conformance to government regulations, industry standards and Company policies. The incumbent will manage the team for regulatory inspections and will assess and advise Executive Leadership on quality decisions. The incumbent will manage interactions with vendors, suppliers and FDA inspectors concerning the quality of products, systems and processes.  The incumbent will identify and manage continuous improvement projects that may span multiple sections or departments with the goal of achieving quality, reliability and cost improvements. The incumbent will manage quality compliance for Contract Manufacturers, will manage GMP and job-specific training program, will manage internal and external auditing, develop a corrective action program to ensure the appropriate responses to deviation or audit deficiencies, review and approve SOP’s, handle production process monitoring, protocol review and batch  record documentation and approval.

Qualifications include B.S. in science or engineering, advanced degree preferred, 10+ years of Quality Assurance in the pharmaceutical products or supplement industry with 7 years of management experience., strong knowledge of FDA government regulatory requirements pertaining to manufacturing of pharmaceutical products or supplements, strong leadership skills and success managing a team, strong analytical and problem solving skills, success working with multifunctional, global teams, excellent interpersonal, communication, negotiation skills, and a high level of human relations skills in selecting, developing and motivating people. Excellent motivational and cross-functional team building skills are required.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Head of Clinical Development – Virtual Role

The Head of Clinical Development provides scientific knowledge of the product lines and reviews and reports on the mechanisms of actions of all active ingredients and the function of the inactive excipients; as well as spearheading the development and discovery efforts requiring a clinical veterinary perspective and coordination of efforts as needed.   Key responsibilities include the design and oversight of late-stage or post-launch clinical programs; locate the appropriate CRO for the product testing and reviewing protocol and budget and receive management approval, plan and coordinate the work in accordance with good science and applicable regulations/guidelines.  The incumbent will monitor studies at critical study time points and report findings in pivotal and non pivotal targeted animal studies in support of new and existing products with strict compliance with applicable regulations; as well as analyze the literature and FDA documents and design clinical strategy for a new product. The incumbent will work closely with marketing and sales pre and post launch of Veterinary and OTC companion animal products to ensure scientific validity to all sales and marketing claims and promotions.

Qualifications include a Doctor of Veterinary Medicine degree and 3-5 years of pharmaceutical research and development experience. Specialty training is a plus. 30% travel is required.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Head of Research

The Head of Research is responsible for analyzing literature and FDA documents and designing clinical strategy for a new product.  The incumbent will keep up to date in the pertinent therapeutic areas as well as writing protocols, consent forms, and helping to design data collection forms.  Key responsibilities may include assessing the risk: benefit of any given product under development or being considered for development; assist in recruiting veterinarian investigators to participate in clinical trials as well as review electronic database of clinical data during a clinical trial to screen for safety issues, adverse events, serious adverse events, and communicating such to the team and to the FDA.  The incumbent will set up and run pharmacokinetic studies with outside contract organizations, including locating analytical lab and in-life study site, and managing the study from start to completion.  The incumbent will make scientific presentations to investigators, staff members, FDA, USDA, and at medical conferences as required.  Additionally, the incumbent will assist clinical staff to clean database and answer medical questions during this process and communicate with investigators regarding enrollment issues, adverse events, and other problems that may arise; as well as work with academic investigators at veterinary schools to undertake clinical laboratory work in dogs, cats, and horses. 

Qualifications include a Doctor of Veterinary Medicine degree and 3-5 years of pharmaceutical research and development experience. Specialty training is a plus. 30% travel is required.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Product Development Manager – Northeast

The incumbent will develop the overall CMC document strategy with Regulatory and CMC leaders and then execute document creation, collation, editing and review. The incumbent will work within a team to ensure consistency, accuracy and flow of message  that Regulatory will submit to FDA-CVM to support new ANADAs, and supplements and amendments to existing applications.

Qualifications include a degree in life sciences combined with experience in CMC technical writing (preparation of CMC/regulatory documentation). The successful candidate will have 5+ years of product development and manufacturing experience in the pharmaceutical industry. Computer literacy is required.  

For immediate consideration,  please Apply Now.