AVP, Quality & Technical Operations

Job Title:

Associate VP, Quality Operations

Location:

Cherry Hill ,NJJob-Type:

Fulltime Job  Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE:

The Associate VP, Quality Operations oversees Quality Operations and Technical Affairs, which includes, Quality Assurance, Quality Control, Quality Systems, Validation & Metrology, and Quality Investigations at the Cherry Hill, NJ and Bedford, Ohio facilities.  This encompasses Chemistry, Microbiology, Environmental Monitoring, QA In-Process, QA Investigations, QA Documentation, Media Fills, Sterility. Assurance, SOP Training, Aseptic Technique Training, Quality Compliance, Product and Equipment Validations, and Manufacturing Calibrations Instrument Services.

This role also ensure that systems and procedures for regulatory compliance are established and deployed, periodically reviews the suitability and effectiveness of quality systems with executive management, and oversees regulatory inspections and technical activities for all or multiple segments of the validation function.

Further, this role is responsible for managing, developing, and implementing validation processes to ensure that equipment, components, processes, and products comply with the applicable regulatory agency validation requirements, internal company standards, and current industry practices, sharing advice and expertise on multiple disciplines to meet business plans.

KEY ACCOUNTABILITIES:

Develop and deploy quality systems (e.g., management review, CAPA, process control) that ensure products conform to defined requirements

Manages the Quality organization for Hikma’s injectable Sites, acting as the Quality Management Representative.  Is responsible for results in terms of product quality and conformance to regulations and policies

Understands and deploy processes to assure conformance to regulations at Hikma’s Sites, managing regulatory inspections

Periodically review the suitability and effectiveness of the quality system with executive management

Assesses and advise senior management concerning acquisition targets

Interact frequently with all levels of internal management as well as across functions and business units

Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility

Direct the Technical Services organization to be efficient, effective and compliant in the execution of Site validation master plans, including product development, client Management and all aspects of a compliant validation program in line with industry best practice

Have responsibility for Site contract manufacturing programs, including cost proposals, validation strategy and plan, technical evaluation and feasibility, liaising with clients, and project management

Initiate, develop, and lead technical feasibility analysis where new and unproven methods and technologies are required.

Manage interactions with customers and regulators concerning the quality of products, systems and processes

Identify and manage continuous improvement projects that may span multiple sections or departments with the…