Description:
Adventure ready brands exists to inspire outdoor adventureWe have a strong history and portfolio of brands focused on enjoying the outdoors (adventure medical kits, ben’s, natrapel, afterbite, rapidpure etc.) and have established a strategy and plan to accelerate growth with key initiatives including relentless sales execution, operational excellence and creating a growth and leadership cultureOur core competencies include customer and consumer focus, results oriented, leadership, innovation and initiative and communication and teamwork.
This role can work in new england remotely, but will be required to report to the littleton, nh headquarters on average twice per week.
Purpose and scope
The qa regulatory compliance manager will define strategic direction for arb`s quality and regulatory complianceThis role will also develop and maintain an inspection readiness program that will ensure compliance with pharmaceutical and medical device gmp regulations.
Essential job functions
Ensure the compliance of adventure ready brands manufacturing and testing activities with respect to adventure ready brand`s procedures as well as fda, eu, ich, health canada, and other regulatory requirements for both drug and medical device products.
Provide leadership for quality compliance activities and initiatives.
Establish program to promote a culture of quality and compliance.
Identifies and documents procedural deviations and discrepancies through auditing, record reviewing, and multi-departmental interactionsProposes corrective actions and verifies effective implementation
Assists in the ongoing maintenance of the quality system
Investigation, evaluation and reporting of adverse events incidents or device malfunctions as required by fda and international regulatory authorities
Perform internal and external audits as assigned
Supports validation of pharmaceutical manufacturing equipment control systems and enterprise resource planning (erp) applications
Reviews cgmp related documents (i.eAnalytical/manufacturing records, stability, protocols, reports, etc.) pertaining to chemical intermediates and apis for accuracy, completeness, and compliance with policies, procedures, and cgmp.
Directs / conducts internal investigations of data integrity compliance issues.
Participates in cross-business / cross-functional teams
Other duties as assigned.
Requirements:
Bachelor degree: chemistry, biology, or any other related science.
Experience working in cgmp environments meeting fda and mhra regulations, and industry best practices
Experienced leader, motivator, communicator, and coach with a strong sense of working in a team environment.
Solid knowledge of technical report writing and computer literate as required.
A minimum of 5 years in a quality or technical field in the medical device / pharmaceutical related business.
Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
