|Carton Service, Incorporated dba Pharma Packaging Solutions|
US-TN, Director of Quality Assurance Regulatory Affairs
Pharma Packaging Solutions (PPS), a pharmaceutical packaging company located in the Knoxville, TN area, is seeking a Director of Quality Assurance & Regulatory Affairs. PPS has been in business since 1995, and is a growing organization specializing in regulated contract packaging solutions which help global, mid-sized pharma and healthcare companies become more strategic and efficient.
The Director of QA & RA will be actively engaged in regulatory strategy and operations, collaborating with all stakeholders to develop and advance PPS’s policies and procedures for regulatory compliance with all applicable agencies. Also, ensuring support of PPS’s regulatory strategy with its growing business strategy is a key. An understanding of today’s pharmaceutical and healthcare industries, their needs and expectations is important, as is the ability to be a key facilitator in creating win-win solutions with internal stakeholders and external customers. The successful candidate must maintain “contributor / manager” leadership skills, meaning he or she is willing to be a manager who is an active, productive associate and leads by example. Calm communication skills are essential.
Primary responsibilities include:
· Manage and develop the Quality Assurance department, including the development of subordinates’ knowledge in general and their technical skills in the QA & RA area
· Oversee the company’s document review and control functions, regulatory submissions, and internal and external audits
· Act as the primary contact and host of the regulatory authorities (DEA, FDA, MHRA, Boards of Pharmacy)
· Act as the primary contact and host of current customer and prospective customer site audits
· Provide strategic input and technical guidance on regulatory requirements to establish a compliant culture
· Interdepartmental teamwork and communication skills are key
· Support of and communication with a packaging operation that often works 5-to-6 days / week & 2-to-3 shifts / day
· Experience with and guidance in controlling potent and/or Schedule II, III, IV and V drug product is beneficial
Candidates must possess at least 5 years of experience in Quality and Regulatory Affairs, preferably in a regulated healthcare industry (e.g. pharmaceuticals (solid dosage form packaging experience is a plus) and medical devices). A Bachelor’s degree in an applicable field is required. An advanced degree and/or Regulatory Affairs Certifications are a plus.
Excellent verbal and written communication skills are crucial, as this role will interact with all members of the pharma supply chain including: regulatory agencies, operations associates, internal Subject Matter Experts, and pharmaceutical executives.
If this position sounds like a fit for your career destination, we look forward to receiving your resume.
Attn: Human Resources
341 JD Yarnell Industrial Parkway • Clinton, TN 37716
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