Specialist, 3PQM - Injectables

Specialist, 3PQM - Injectables

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 Specialist, 3PQM - Injectables to join our team. In this role, you will be responsible for Quality management of third-party manufacturing (3PM) activities at contract manufacturing organizations (CMOs) used by Hikma Cherry Hill including Hikma Cherry Hill contract manufacturing customers, external development projects and business development activities involving external partners.

Ensures that the quality management system is being followed and maintained within 3PM in line with the Hikma Cherry Hill pharmaceutical quality system (PQS) and regulatory expectations. Also ensures regulatory compliance and high-quality standards of products manufactured at the assigned CMOs. Scope may include multiple countries.

Key Responsibilities :

• Represents 3PM Quality in cross-functional meetings such as technology transfer projects, launch and NBO (new business opportunity) projects. Performs due diligence PDR's (product design review) and joins technical visits at CMO's.
• Participates and facilitates in quality meetings with CMO's and representing WW as a CMO, annual CMO ratings and Business Review Meetings. Identifies risks, and works with leadership on risk mitigation measures.
• Supports 3PM 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 of QAA and routine review / revision of QAA's as required.
• Prepares monthly data reviews tracking performance of CMOs.
• Writes, and reviews internal and external deviation reports and CAPA's.
• Manage reporting and timely closure of customer deviations and CAPA.
• Ensures effective root-cause analysis (RCA) is conducted and that the CAPA process at the CMOs is implemented effectively.
• Manage changes that can have an impact on either material, equipment, documentation, process and / or formulation for products.
• Serves as a Quality contact at the assigned CMOs / out-licensees and contact for quality issues with CMO / out-licensees and at WWC / CMO interface. 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 WWC Quality requirements and local procedures.
• Writes, updates, and reviews SOPs and ensures congruence with good manufacturing practice (GMP) and WWC PQS 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 accordance with the approved procedure and schedule.
• Work with regulatory compliance to complete the annual audit risk assessment.
• Reviews master batch documents, product specifications, validation reports and any other miscellaneous documents associated with batch production. Maintain processes consistent with WW procedures and requirements.

Qualifications :

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them :

Bachelor's degree in scientific field required; Chemistry, Pharmaceutics, or biology preferred. At least 1 year of experience in a regulated, pharmaceutical environment. Experience can be any combination of Quality Assurance, Quality Control, Change Management, Project Management, Supplier Management, Process / Product Validation, Regulatory Compliance, or roles with extensive responsibility in aforementioned areas. Demonstrated understanding of requirements across multiple countries and the ability to communicate effectively across cultures is desired. Demonstrated communication, negotiation, relationship building, influence, time management, and problem-solving skills.

Preferred Qualifications :

Compensation : Base Salary : $66,600.00 to $133,750.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer :

Equal Opportunity Employer : Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.