GMP Quality Assurance Manager
Proclinical is currently recruiting for a GMP Quality Assurance Manager for a global Pharmaceutical company located in Cambridge, MA. Successful candidate will support the overall coordination of the quality systems, including documentation, training, deviation/OOS/CAPA, product complaint, change control and LIMS.
- Support daily operations and quality systems.
- Track overall compliance of training activities and expertise for GxP and guidance for Non-GxP audiences.
- Act as primary contact and support for training and documentation related questions and issues.
- Assist with the development and administer the training in support of regulated activities.
- Provides support developing strategies to ensure best practices are incorporated into the development of documented procedures and specified required training (globally, cross-functionally and regionally).
- Provide advice and expertise to employees to ensure the development, management and implementation of controlled documented procedures and business critical policy and procedures with associated training.
- Responsible for quality oversight of GxP document lifecycle states in the DMS.
- Responsible for management of GxP training assessments and assignments to applicable personnel.
- Coordinate quality events/processes (deviation, change control, etc) and support review board activities as applicable.
- Support quality metric reporting and periodic assessment of the health of quality systems.
- Support the product complaint triage process to ensure compliance with procedures/processes.
- Support process and technology initiatives for quality systems; participate in continuous improvement projects.
- Administer training for quality systems, which may include specific user training or training globally.
- Author and maintain procedures supporting quality systems maintaining compliance with regulations and policies
- Generate reports, monitor training compliance and perform tracking and trending of relevant training data. Identify and evaluate gaps and develop corrective actions to close gaps.
- Ensure new personnel have appropriate GxP training assignments and provide new hire training for applicable quality systems
- Contribute to create and communicate an employment culture and values which attract, retain, and develop the most effective people.
Skills and Requirements:
- Bachelor's degree in a scientific discipline with 5 years of experience and 3 years working in Quality Compliance or Systems within the pharmaceutical or related industry, including 3 years in a GMP Quality Assurance role. Experience may be substituted for a degree.
- Experience in administration and/or management of GxP documentation, training and quality event/process systems
- Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels
- Well organized and detail-oriented; must be able to effectively prioritize work
- Eager to learn, interact cooperatively and effectively with others in a team environment.
- Possess advanced word processing, data entry and data presentation computer skills.
- Excellent communication skills, both oral and written.
- Experience in Labware, Trackwise, Assurx, QUMAS, NetDimensions, SAP or related systems a plus.
- Ability to influence and work effectively with various business partners in multiple regions and cultures.
- Strong project management skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.