Manager, Document Control & Training
Location: Bedford, MA
As a Document Control and Training Manager, you will be responsible for ensuring effective local and inter-company oversight of the Document Control and Training Quality Systems to meet both regulatory and customer expectations including harmonizing with quality standards and simplifying processes while driving both compliance and efficiency.
Strategic Focus Areas:
- Provide leadership for global document control and training compliance activities.
- Partners with department heads to ensure delivery of project plans for on the job training, qualified trainer program and new hire orientation.
- Create a positive image of Anika through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate government and regulatory authorities
- Manages the global electronic GMP/GDP documentation and Training system in compliance with regulatory and Anika requirements.
- Identifies and implements quality system improvements for document control and training processes and procedures based on performance metrics and stakeholder feedback.
- Provide training or create training programs on the electronic and physical record GMP documentation system.
- Develop, configure, and implement effective and efficient processes, procedures, and systems for electronic and physical record management.
- Ensures alignment between procedural changes, training strategy and training materials.
- Develop and report documentation system KPIs, metrics and report in management review meeting.
- Periodically conducts internal auditing activities to ensure that systems are operated in accordance with established SOPs and GMPs.
- Participate in cross-functional teams as subject matter expert for electronic documentation and training systems; partners with department heads to ensure delivery of project plans for OJT, qualified trainer’s program, new hire orientation, and alignment to regulatory standards.
- Participate in cross-functional teams as subject matter expert for electronic documentation and training systems to support new product launches, new market opportunities, and other initiatives.
- Manages the transfer of Quality documents and records to on-site and offsite archive.
- Supports preparation for regulatory agency inspections and participates as a Subject Matter Expert during regulatory GMP inspections and internal audits.
- Have a good understanding of the regulated medical device industry including experience with FDA Quality System Regulation, ISO 13485, cGMPs, EU MDD and EU MDR.
- Responsible for other duties and projects as assigned
Assignments are defined by objectives and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance.
- Bachelor’s Degree in a technical or scientific discipline.
- Minimum of 6 – 8 years of experience in the medical device and/or pharmaceutical industry and 2-3 years direct experience managing Documentation System and Training departments using an electronic system.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
- Excellent presentation skills, both written and in platform presentation format.
Desired Experience, Knowledge, and Skills:
- Demonstrated experience building strong partnerships.
- Demonstrated experience delivering results in a fast paced, hands-on organization requiring high energy.
- Ability to work autonomously, effectively manage time and deliver results on time.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.