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R&D Compliance Documentation Manager

Country : USA

State : New York

County : Suffolk County

Town : Melville

Category : Consulting - Audit

Contract type : Permanent

Availability : Full time

Job description

In this role, you must utilize your expertise and knowledge of regulated industries to support the development to commercialization of regulated goods. The ideal candidate will lead a team utilizing existing capabilities & systems to actively seek out & addresses opportunities to build / improve systems and processes. Engage cross functional departments (development teams, supports groups, quality, manufacturing and international geographies) to promote efficiency and agility. This R&D position partners with development, manufacturing, packaging and quality. Among other functions you will guide team members developing/improving processes, ensuring procedures are followed, reviewing documentation, to support the commercialization of finished goods. Providing guidance on the established process to drive the combination of cross functional requirements to facilitate product launch to market. Independently takes action, evaluates, summarizes and reviews information to drive a complex process. Interprets unexpected results and works across disciplines to obtain clarification or data/documents as required. Compile and maintain technical documentation (technical files) required for compliance. Participate in cross-functional meetings to provide guidance, identify gaps and address concerns during the product development. Have a firm grasp on the quality system requirements, corporate policies and procedures needed to support product launch, guide cross functional teams to reach a common end goal.
- Decision Making - Lead a team of employees that Compile Cross Functional Data required documents to support product launch. Attend meetings and provide status and guidance. (75%)
- Process Efficiency/Improvements- (20%) - Investigate new or existing tool to build efficiency in the current process, update systems and policies to align
- Problem Solving (25%) - Identify gaps and provide support to proactively alleviate potential snags in the process.

Profile

- Bachelors Degree in Physical Science or Business Analytics, . Master's preferred
- Specialized experience in the development work needed to commercialization regulated products
- Strong cGMP knowledge specifically OTC, FDA, Commercialization
- Ability to guide team and ensure standards are followed
- Ability to collaborate effectively with teams outside of R&D
- Must have excellent communication skills (Written & Verbal).
- Ability to work nimbly, and have strong problem solving skills
- Strong organization skills
- Microsoft office skills.
- Multitask
- Detail oriented, superior review skills -7 Years Minimum Experience
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