Sr. Manager - Manufacturing Quality

Purpose: Our client, a local pharmaceutical company, is seeking a Senior Manager for their Delivery Systems Manufacturing Quality group.


RESPONSIBILITIES:

Reporting to the Director of Manufacturing Quality and working with critical internal and external customers, develop and lead the team responsible for quality and compliance oversight at investigational and commercial device-related contract manufacturing service providers. Ensure the review and/or approval of master batch records, executed batch records, manufacturing data, and other batch-specific manufacturing documentation as part of the overall batch disposition process for device-related products. Manage the initiation, investigation, review, approval, and/or closure of device-related quality complaints, deviations, corrective and preventive actions, and change control requests. Coordinate and manage Quality-related device needs (e.g., design history).

-Provide assistance to Regulatory Affairs related to device applications (e.g., 510(k)) as well as Product Development for design related issues.
- Review and maintain Device Master Records.
-Participate in the review and revision to Quality Agreements with device-related commercial contract service providers.
-Assist in the coordination and compliance with requests of regulatory authorities during internal inspections and during inspections of contract service providers..
-Review and approve device-related internal and external change requests. Ensure proper implementation.
-Ensure that proposed changes are consistent with applicable regulatory requirements and determine if the changes affect a regulatory submission or require communication to regulatory authorities. Assist in the preparation of relevant regulatory documentation.
- Manage device-related product complaint manufacturing investigations (investigational and commercial).
- Work with relevant technical experts to ensure that corrective and preventive actions associated with manufacturing-related activities are addressed and implemented.
- Review and determine the acceptability of deviation reports and proposed corrective and preventive action plans for devices.
- Ensure compliance with applicable regulatory requirements for devices and ensure a design history file is developed, maintained, and made available for regulatory authorities, as appropriate.
-Ensure appropriate cGMP documentation is generated, revised, approved, and maintained.
- Ensure the labeling, packaging, storage, shipping, and distribution programs of device-related contract service providers are assessed and ensure compliance to quality aspects of commitments and agreements made to.
-Ensure batch-specific documentation is reviewed and/or approved.
-Assist with the compilation of product-related documentation, including validation activities, to support regulatory filings (e.g., NDA supplements).
-Identify and/or assist in the resolution of potential or existing quality issues that may jeopardize cGMP compliance or regulatory position.
-Develop compliant solutions when confronted with obstacles in a timely fashion.
-Ensure the review and/or approval of batch-specific manufacturing-related documentation (e.g., executed batch records, deviations, investigations).
- Provide quality support to device-related process validation and quality improvement initiatives.
-Systematically plan, forecast and set objectives for staff members to meet project timelines.
-This position will involve the supervision of employees. This position will require travel of approximately 10% - 30%.

This person will have a science degree with at least 10 years experience in the medical device industry is required; direct experience with injectibles and combination products or other pharmaceutical products is highly desired. Experience supporting commercial medical devices in a Quality Assurance role is essential including a thorough understanding of US (QSR) and non-US device quality systems and regulatory expectations. Experience interacting with third parties (e.g., contract service providers) preferred. Experience with device related regulatory filings preferred.

For consideration please send resumes to Simone Ando at