Sr. Specialist, Third Party Manufacturing

Job Title: Sr. Specialist, 3PQM

Location: Columbus, Ohio

Job Type: Full Time

Req ID: 7128

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, 3PQM to join our team.  In this role, you will be responsible for Third Party Quality Management (3PQM) of third party finished product manufacturing (3PM) relationships between Hikma and contract manufacturing organizations (CMOs). This also includes Supplier Quality management activities for third party customers for which Hikma is the finished product contract manufacturer, private labeling relationships, re-packaging relationships, external development projects and business development activities involving external partners. Ensures that the quality management system is being followed and maintained at the CMO and is  in line with the Hikma pharmaceutical quality system and regulatory expectations. Also ensures regulatory compliance and high quality standards of finished products manufactured at the assigned CMOs.  Scope may include CMOs located in multiple countries

 

Key Responsibilities:

• Represents Hikma Third Party Quality Management in cross-functional meetings such as technology transfer projects, launch and new business opportunity projects. Performs due-diligence product design reviews and joins technical visits at CMOs.
• Facilitates quality meetings with CMOs and represents Hikma as a CMO.  Generates annual CMO ratings and presents the ratings in Business Review Meetings. Identifies risks and works with leadership on risk mitigation measures.
• Supports in setting up quality relevant contracts, both for contract manufacturing and other business models (e.g., co-marketing, co-promotion, out-licensing, repackaging) to support product launches and new business opportunities
• Responsible for the preparation and negotiation of Quality Assurance Agreements (QAA) and routine review/revision of QAAs as required.
• Prepares periodic data reviews tracking performance of CMOs.

• Writes, and reviews internal and external deviation reports and CAPA's. 

• Manages reporting and timely closure of customer complaints, deviations, and CAPA.

• Ensures effective root-cause analysis is conducted by the CMO and that the CAPA process at the CMO is implemented effectively.

• Manages changes that can have an impact on either material, equipment, documentation, process and/or formulation for products.

• Serves as a Quality contact to the assigned CMOs\third party customers and contact for quality issues with CMO\third party customers.   When necessary, escalates issues to resolve conflicts promptly and minimize risk to the organization.

• Provides support to all activities associated with product market actions e.g. recalls according to the Hikma Quality requirements and local procedures.

• Writes, updates, and reviews SOPs and ensures congruence with good manufacturing practice (GMP) and Hikma pharmaceutical quality system and Quality Manual.  Ensures that the Quality System is applied and that all activities are performed according to the local Quality System and SOPs.

• Supports the product quality review (APR/PQR) activities for the assigned products\CMOs by assessing the PQR for product trends that may need to be addressed.  Ensures that the APR/PQR is performed in acc