Job # 604299
Pharmaceuticals/Device Company is looking for:
POSITION: External Manager, Quality Assurance – Sterile and Devices
LOCATION: Florham Park, New Jersey 07932
SALARY: $135-145K + Bonus
EXPERIENCE: 7-10 Years Progressive Quality background in BOTH Sterile Products and Medical Device
RELOCATION: Assistance Available.
This role is part of team that has primary responsibility for providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations) to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs). This position interacts extensively with manufacturing sites, contract manufacturers, and with sites outside the U.S. which manufacture products that include sterile and medical devices products. The individual works closely with the Contractor, Quality Control, Planning and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with cGMPs and regulatory submissions.
Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of company in accordance with cGMPs and Company Quality directives.
Ensures the efficiency of Quality System implemented between Company and the sub-contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements.
Strengthens the Quality and Regulatory strategy particularly during crisis management and verifies the implementation of the relevant action plans.
Support the External Manufacturing North America Audit Program by working with and conducting contractor audits to assure compliance to Company Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings. Leads or participates to the subcontractors audits and manages the CAPAs that follow.
Support projects as assigned such as new product launch teams.
Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to Company products.
Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.
Participates with subcontractors to find solutions concerning quality issues.
Respond to customer complaints, including close out and determination of corrective actions.
Identify and prevent or resolve issues that could impact the continuity of supply of existing products.
Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.
Regular and frequent contact with vendors through formal meeting (systematic business review meeting) or informally when issues can't wait.
Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality.
Regular contact with Legal to ensure the compliance of the activity to all laws and in preparation of Quality Agreements.
Collaborate with numerous country's affiliates' Heads of Quality.
Excellent oral and written communication skills in cGMP documentation.
Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience
Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship
Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
Effectively communicate at all levels of associates in the Company organization (from operator to vice president) or supplier and customer at all levels (including CEO)
The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations
Thorough knowledge of GMP's and regulatory requirements (including Sarbanes Oxley)
Project management skills