Head of Industrial Operations, North America (CMO, Supply Chain)

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Head of Global Supply Chain

Direct Reports: Directors and Associate Directors, Industrial Operations

Areas Managed: Technical Operations

Overview

The Head of Technical Operations, North America, serves as a key executive within Recordati North American subsidiary, overseeing Technical Operations to support the company's marketed products, lifecycle initiatives, and development compounds. This role is responsible for setting the manufacturing strategy to achieve strategic and financial objectives and ensuring compliance with quality standards and regulatory requirements for products sourced through third-party partners.

While part of Industrial Operations organization, the Head of Industrial Operations is an integral member of Recordati North America senior management team, overseeing Manufacturing (including contract manufacturing partners), Supply Chain operations, CMC Development, and Pharmaceutical Development activities. Partners collaboratively and frequently with quality and North American departments in achievement of objectives.

Essential Duties And Responsibilities

• Develop and implement comprehensive manufacturing and supply chain strategies, policies, procedures, and risk-management plans.
• Oversee manufacturing suppliers (API/DS/FP), lead product operations teams, and collaborate with HQ Tech Transfer team, product process innovation, and MIP.
• Manage Supply Chain operations including forecasting, demand planning, logistics, and inventory management.
• Direct inventory/demand, production planning, and distribution activities supporting the commercial product portfolio.
• Handle Alliance Management tasks such as vendor selection, contract negotiation/management, ABRs, and procurement.
• Lead CMC Development efforts for the North American product portfolio, including analytical method development/validation and lifecycle management initiatives.
• Establish and manage operational plans and budgets supporting commercial supply, lifecycle initiatives, and CMC development programs.
• Provide strategic and tactical guidance to cross-functional teams throughout the product lifecycle.
• Collaborate with Regulatory Affairs and Quality Compliance colleagues to maintain product documentation files, manage regulatory CMC reporting obligations, and ensure compliance with cGMPs.
• Liaise with Global/Corporate Functions for efficient synchronization of North American Hub operations with global product strategy and development programs.
• Provide leadership over technical due diligence initiatives, supplier selection, and management of contracts/supply terms/technical agreements.
• Ensure adoption of suitable metrics to evaluate manufacturing and supply chain performance and implement strategies for sharing information and knowledge across the organization.
• Act in full compliance with all laws, regulations, and policies including adverse events/pharmacovigilance responsibilities.
• Perform additional duties as assigned.

Education And Experience

• Bachelor’s degree in management, Chemistry, Life Sciences, or Engineering (with a preference for Masters or Doctoral degree in a related discipline) accompanied by over 15 years of professional experience in industrial operations/CMO/Supply Chain
• Demonstrated project management experience.
• Experience in people management is a must
• Experience dealing with matrix organizations is essential.
• Has experience in what great looks like and is able to bring a structured approach in a fast-growing organization
• Global experience, especially experience with regulatory authorities in multiple markets.

Knowledge And Skills

• Solid understanding of pharmaceutical and biotechnical manufacturing and supply chain processes.
• Strong understanding of cGMPs and Quality System principles.
• Demonstrated ability to lead and influence within an organization and with external partners.
• Excellent negotiation skills and strong analytical skills.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, the employee may be required at times to attend meetings including travel out of state over weekends and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• This position is based at RRD’s Headquarters in New Jersey.
• Approximately 20% travel (domestic and international) required.

FLSA Classification

• This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.