AVP, Quality & Technical Operations

About the role

Location: Cherry Hill, NJ. Full-time position.

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.

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 ensures 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.

Responsibilities

• Develop and deploy quality systems (e.g., management review, CAPA, process control) that ensure products conform to defined requirements
• Manage the Quality organization for Hikma’s injectable Sites, acting as the Quality Management Representative
• Be responsible for results in terms of product quality and conformance to regulations and policies
• Understand 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
• Assess and advise senior management concerning acquisition targets
• Interact frequently with all levels of internal management as well as across functions and business units
• Be 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 objective of achieving quality, reliability and cost improvements
• Consistently develop and execute innovative theories and technologies
• Understand and integrate information from more than one discipline and apply to complex problems requiring innovative techniques
• Participate in global task forces and committees
• Be accountable for critical strategic and operational decisions (e.g., milestones, technical due diligence)
• Develop budgets and ensure adherence
• Perform other duties as assigned
• Maintain regular, predictable onsite attendance and punctuality

Qualifications

• Bachelor’s degree in Science or Engineering; advanced degree preferred
• Minimum of 15+ years of progressive Quality, Manufacturing, or related field experience
• At least 7+ years of management or leadership experience within pharmaceutical manufacturing
• Experience managing others both internally and externally
• Demonstrated experience supporting injectable manufacturing operations; oral, including solid dose, experience is a plus
• Establishing strategies and leading Quality organizations and technical operations
• Strong understanding of injectable and, more generally, generic pharmaceutical manufacturing environments and associated quality systems and operations

Skills

• Proven experience and process knowledge in pharmaceutical manufacturing / packaging technology, engineering, maintenance and technical operations
• In-depth knowledge of the regulatory environment for the manufacture of pharmaceutical products
• Strong knowledge of cGMP requirements, validation principles, human factors, quality systems, regulatory expectations and industrial safety
• Proven ability to influence and collaborate with stakeholders at all levels, including executive leadership, regulatory agencies, suppliers, customers, and global teams
• Exceptional leadership, coaching, mentoring, and talent development skills, including guiding senior-level professionals and leading organizational transformation initiatives
• Results-oriented leader with a strong focus on safety, quality, compliance, delivery, and cost performance
• Strong analytical, problem-solving, and data-driven decision-making abilities
• Highly effective communicator with exceptional verbal, written, presentation, and executive communication skills; able to translate complex technical and quality information to a diverse audience
• Self-motivated, detail-oriented team player with the ability to work effectively in domestic and international environments

Additional considerations

Significant travel expected to support operational needs.

Pay

Base salary: $182,000 to $331,250. 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.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay; Hikma will match 100% of the first 6% of eligible pay that you contribute
• Generous paid time off (PTO) bank starting with 20 days (prorated based on hire date); additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.