Title:  Director, Quality Operations

Job Title: Director, Quality Operations

Location: Bedford, OH

Job Type: Full-time

About 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.

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 Director, Quality Operations to join our team.  In this role, you will be responsible for for ensuring that our pharmaceutical Injectables in the US meet and exceed the highest industry standards for safety, efficacy, and compliance. You will implement our strategic direction, oversight, and leadership to our Quality department, fostering a culture of continuous improvement and adherence to regulatory requirements.

Key Responsibilities:

Strategic Quality Implementation Leadership:

• Implement strategic direction and leadership in the development and implementation of quality standards, policies, and procedures across the US organization.
• Implement the company's quality strategy, aligning it with the overall business objectives.
• Provide direction for quality initiatives implementation, ensuring they support product excellence, compliance, and customer satisfaction.

 Regulatory Compliance:

• Ensure that all manufacturing, packaging, labelling, and distribution operations of the company's injectable and sterile product portfolio comply with applicable local and global regulations and industry standards, e.g. FDA, EMA, GCC and cGMP guidelines and CFR 820 requirements for combination products and processes.
• Lead interactions and manage inspections and quality audits, both internal and external (FDA/EMEA), and establish corrective and preventive actions to address identified deficiencies.

Quality Systems and Processes:

• Implement, maintain, and continuously improve effective quality systems (QMS) to ensure it meets or exceeds industry standards.
• Drive the implementation of robust quality control and assurance processes.

 Quality Assurance and Control:

• Direct the activities of the Quality Assurance and Quality Control teams, ensuring product quality at every stage of the manufacturing process.
• Implement effective measures for batch release, stability testing, and deviation management.  This includes Document Control, Change Control, Deviation & CAPA Management, and Batch Record Review.

 Quality Sterility Assurance and Environmental Monitoring Control:

• Develop and implement microbiology lab and sterility assurance strategies, policies, and procedures for the company's manufacturing facilities.
• Develop and implement microbiology strategies, policies, and procedures for the company's manufacturing facilities, including environmental monitoring, microbiological testing, and microbial identification.
• Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
• Oversee the risk assessments program and root cause analyses for sterility assurance and microbiology issues and support in developing an effective corrective and preventive program.

 Validation / Qualification of Equipment:

• Ensure the development and implementation of Hikma’s validation philosophy and approach.
• Ensure the development and implementation of Hikma’s Validation Policy, validation framework and holistic Validation Master Plan (VMP)
• development and implementation of Hikma’s validation standards and standard operating procedures.

Compliance Training and Education:

• Ensure the proper development and delivery of comprehensive training programs for employees at all levels, emphasizing compliance with relevant quality standards and regulations. 

Supplier and Vendor Quality Management:

• Establish and oversee a comprehensive vendor qualification and management program, ensuring that suppliers meet our quality expectations.

Quality Metrics and Reporting:

• Define and monitor key performance indicators (KPIs) to track the effectiveness of quality initiatives and provide regular reports to senior management. 

Risk Management:

• Implement risk-based approaches to quality management, identifying and mitigating potential quality risks across the organization. 

Networking [Internal/External]:

• Collaborate with cross-functional teams, including R&D, Manufacturing, Supply Chain, and Regulatory Affairs, to ensure product quality and compliance throughout the product lifecycle.

• Stay current with industry trends, new regulations, and emerging technologies related to injectables and sterile manufacturing, and provide recommendations to senior management on quality improvements and risk mitigation strategies.

 Team Development:

Attract, manage, and develop a high-performing Quality Assurance team by providing coaching, mentoring, and professional development opportunities

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 pharmacy, Chemistry, or related field.  Advanced degree is preferred.
• Minimum of 15 years of progressive leadership experience in Quality Assurance roles within the pharmaceutical industry, with a strong focus on injectables and sterile manufacturing.
• In-depth knowledge of local and global regulatory requirements and Quality Standards for Injectable Pharmaceuticals such as FDA regulations and guidelines, GMP, and ICH guidelines.
• Must possess a strong knowledge of quality systems for parenteral drug products per CFR 210/211 and combination products per CFR 820 requirements related to prefilled syringe and intravenous bag manufacturing. 
• Experience in sterile manufacturing of aseptically filled and terminally sterilized processes, sterility assurance and sterilization validation. 
• Strong understanding of Quality Management Software Systems and Tools, including document control, change control, deviation management, and batch record review.
• Proven track record of successfully leading and managing Quality Assurance functions and teams in a fast-paced, highly regulated environment and driving a culture of Quality and Compliance.
• Experience conducting and managing internal and external audits, including interactions with regulatory authorities.
• Excellent leadership, communication, and problem-solving skills with ability to effectively interact with internal teams, external partners and regulatory agencies.
• Strong analytical skills and attention to detail.
• Ability to work collaboratively with cross-functional teams Internationally and influence at all levels of the organization.

Compensation:

Base Salary: $121,350 to $220, 850 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*:

• 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
• A 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.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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.