Manufacturing Quality Manager
Personal Genome Diagnostics (PGDx) is seeking a detail-oriented and collaborative member to join the Quality Team at PGDx. The primary responsibilities of the Manufacturing Quality Manager are to develop and maintain the Quality batch disposition program, ensuring adherence to, GMP (QSR 820) regulation, ISO 13485:2016 and other standards/ governing regulations applicable to PGDx. In addition, the Manufacturing Quality Manager is responsible for oversight of the Supplier Quality Program and maintaining the Safety Data Sheets (SDS) program. The Manufacturing Quality Manager will provide a broad scope of technical knowledge in processes such Product Disposition, Nonconforming Product Investigations, Supplier Evaluation, OSHA-EU Chemical classification and labeling.
- Lead the development and implementation of the Product Disposition program. Specifically, gap assessment the existing program, identify any risk, develop a CAPA plan and lead the rollout of a regulatory inspection ready Product Disposition program.
- Lead the development and implementation of the Supplier Qualification program. Specifically, gap assessment the existing program, identify any risk, develop a CAPA plan and lead the rollout of the Supplier Qualification process. Coordinate initial and routine qualification of suppliers ensure that Supplier qualification status is current, any corrective actions are monitored, and appropriate closure activities are captured and aligns with regulatory expectations.
- Provide technical assistance in the development of PDGx’s Quality Management System documentation to support the company’s IVD products.
- With support from the Compliance Manager, Lead the development and implementation of the post market Nonconforming Product program. Specifically, gap assessment the existing program Sop, identify any risk, develop a CAPA plan and lead the rollout of a regulatory inspection ready Product Complaint program. Lead the nonconforming product investigation, ensuring that associated program requirements such as Supplier notification (SCAR), Product Recalls, etc., are executed and defendable. Host MRB meetings, including ensure key members of leadership are included in the investigation and decision-making process.
- In collaboration with Operations, develop and implement the UDI program.
- Lead Manufacturing Quality Inspection Readiness activities by developing the IVD Manufacturing In-Phase Audit Program. This includes but is not limited an Audit process that ensures manufacturing program end to end is audited on a frequency against 21CFR820, ISO 13485 and other applicable Regulations and Standards. Develop the Audit schedule and ensure it supports GMP, ISO and other applicable standard requirements. Ensure audits are carried out, reports are generated, CAPA are assigned. Report the results of the Audit Program to Leadership as part of trending and management reviews.
- Recommends solutions to Quality and Site leadership on Manufacturing Quality and Supplier Quality program improvements.
- Represents Quality in interactions with internal functional units on Quality Manufacturing, Supplier Quality and SDS topics.
- Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
- Train/Coaches employees at various experience levels and provide technical guidance and feedback on IVD regulation and compliance requirements.
- Provide Good Documentation Practice training.
- Provide support and assistance during regulatory or partner audits, as appropriate and as directed by supervisor and the Management Representative.
- Facilitating SCAR investigations and status meetings.
- Implementing Dash Boards and Trend Reports.
- Work closely with the investigation team and lead investigators to assess CAPA effectiveness and CAPA Plans.
- Presenting Manufacturing Quality and Supplier Quality Program to regulatory, ISO 13485 or partners, as part of inspections and audits.
- Presenting Manufacturing Quality and Supplier Quality Program Status at Management Review as required.
- Lead Quality Events (Manufacturing Quality and Supplier Quality) and CAPA Effectiveness Closure Activities.
- Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree in Engineering or Science
- Minimum of 10-15 years in medical device or IVD products manufacturing within Quality.
- Strong knowledge in QSR/ISO 13485:2016 Compliance requirements
- Well versed in ISO 13485 and 21cfr820
- Strong analytical, organizational, communication, and interpersonal skills are required
- Must be assertive and courageous in ability to share differing viewpoints and perspectives
- Critical thinking ability and attention to detail
- Effective technical writing ability and verbal communications skills
- Computer skills including MS Office
ABOUT PERSONAL GENOME DIAGNOSTICS
Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information
from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy
genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer
researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic
technologies for drug development and clinical practice.
Please submit applications (cover letter and resume) to HR@personalgenome.com
Special consideration will be given to internal PGDx employees who apply.
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