DPS is looking for a Senior Quality Compliance Specialist to support a client in Norwood, MA.
- Partnering with other members of the Quality team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures
- Support quality systems programs and processes by being a liaison to manufacturing with investigations into product or manufacturing process
- Assist in the creation and modification of Quality System procedures and related documentation
- Review and approval of deviation cases and corrective action plans (CAPA)
- Plan, conduct and document internal audits. Evaluate findings and report these to the respective department and upper management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of DPT's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
- Supports the evaluation of the impact of proposed process changes, deviations, and CAPAs on the end-to-end supply chain.
- Create, publish, and maintain metrics and reports associated with QMS
- Carries out quality system due diligence and integration activities as required by the business
- Performs standards and regulation gap analysis as applicable to QMS
- Facilitate cross-functional team risk assessment discussions in support of major/critical deviation investigations and change controls and draft risk assessment report documents as per defined timelines.
- Additionally, the individual would monitor and communicate quality compliance performance indicators and related reports and metrics to the leadership team
- Compile data and generate Annual Product Reviews/Product Quality Reviews. Adhere to timelines outlined in pertinent standard operating procedures (SOPs) and communicate the due date to respective departments and upper management.
Skills & Qualifications
- Requires BS/MS degree in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience, preferably in pharmaceutical or biotech Industries, including some supervisory and/or leadership experience.
- Minimum 5-7 years QA, RA, Manufacturing, or Compliance experience in the pharmaceutical industry at USFDA-regulated facilities
- Proficiency in report writing, analysis, and QMS procedures.
- Previous experience with Data Reporting to support Quality Management Review and APQR
- Experience with pulling Quality System Metrics from Veeva (or similar QMS)
- Strong CAPA acumen and change control workflow experience
- Strong ability to evaluate metrics and data reporting for key takeaways (e.g. On-Time Deviation closure rates)
- Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports, and regulations to make decisions in GMP environment
- Highly proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems is heavily preferred
- Possess excellent interpersonal, written, and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
- Ability to work independently.