Cambridge, Massachusetts
Sr. Manager/Associate Director, Auditing & Compliance Job Opening in Cambridge, Massachusetts - Sr. Manager/Associate Director, Auditing & Compliance
Primary Role
Manage an internal audit and vendor audit program for GMP, GCP and GLP compliance, working closely with Boston Biomedical?s operational functions to define the processes and systems to be audited annually.
Responsibilities
Manage and maintain internal audit schedules, ensuring that audits are conducted, corrections are completed and metrics are evaluated, and then presented to management on a timely basis.
Prepare and maintain Quality Agreements with CMOs, CROs and Clinical Sites with which Boston Biomedical has a new or existing relationship.
Conduct QA audits at facilities with which contractual relationships have been established. Audits include protocols, data, reports, test methods and SOPs for Boston Biomedical projects in addition to GMP, GCP or GLP compliance.
Create and implement a systematic approach for the conduct of all audits to assure consistency in the approach.
Ensure that all technical and manufacturing operations are performed in accordance with FDA and/or EMA GMP regulations, relevant FDA or EMA , study protocols and internal SOPs.
Review progress toward closure of audit findings and report progress to management. Additionally, perform follow-up on all supplied information in order to perform verification checks on proposed corrective actions.
Prepare reports and action items from areas impacted during audits that support or risk compliance of the facility.
Manage and maintain internal audit schedules, ensuring that audits are conducted, corrections are completed, and metrics are evaluated and presented to management on a timely basis.
Provide backup support for the QA Document Control function.
Requirements
Bachelor?s degree in a relevant scientific discipline.
Minimum of six years of QA experience which includes auditing for solid oral dosage form products.
Strong grasp of issues relating to GMP, GCP and GLP compliance.
Ability to function effectively under minimal supervision and to independently develop solutions to moderately complex problems.
Excellent understanding of the importance of being flexible in an environment with changing priorities, processes and deadlines.
Strong understanding of the required structure and content of submission documents.
Ability to function effectively with strong communication and interpersonal skills in a team-based environment.
Additional Details: Job location: Cambridge, MA
Job Type: Full-time
Required education:
Bachelor's
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