Cambridge, United States
about 2 years ago
QC Compliance Manager
- Responsible for the daily management of compliance commitments including driving the implementation of external commitments, leading deviation investigations, and working cross functionally to support on time release of product.
- Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
- Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
- Ensure high levels of communication with team, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
- Partner cross-functionally to implement process improvements; participates and/or may lead cross functional projects. Acts as compliance subject matter expert for assessments for change controls, validation protocols, and document changes with respect to the QC department.
- Exhibits strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Provides effective written or verbal communication to peers, quality staff, and area management within their operational group.
- Technical understanding of Microbiological and Analytical Tests and GMP processes needed to aid in technical conversations and investigations.
- Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to area management.
- Bachelor's degree and 6-8 years of related work experience or Master’s degree and 4-6 years of work experience. Preferred experience working in 2 or more functional areas.
- Minimum of 3 years in cGMP Quality Control operations in a fast paced production environment.
- Demonstrated ability to manage cross-functional teams and collaborate across the business.
- Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
- Expertise in managing small and medium QC compliance related projects.
- Demonstrated ability to present ideas persuasively and negotiate effectively.
- Excellent written and oral communication skills both internal and external.