Quality Assurance Manager

ID: 710

Date of Posting: Jun 26, 2024

Job Family: Quality

Job Type: Direct Employee

On site / Remote / Hybrid: On Site

Location:

Bridgewater, NJ, US

Territory

Shift: Full Time

Seniority: Not applicable

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, 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 devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Deputy Chief Pharmaceutical Officer, Head of Quality & CMO Quality

Direct Reports: None

Area Managed: Quality Assurance – GMP / GDP)

Overview

The Quality Assurance Manager will play a key role for the North American manufacturing and quality organization, in managing activities related to Good Manufacturing Practices (GMP), in connection with CMOs and with the local RRD Inc. affiliate responsibilities. Where appropriate the role will support the Good Distribution Practices (GDP) activities that are in connection. In addition, this role will perform critical quality assurance activities such as Change Management, SOP Management, and Audit oversight. The role will develop and implement programs to establish and maintain quality standards of existing products and services as well as developing programs to focus employees on quality improvement.

Essential Duties And Responsibilities

• Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. This includes documentation control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems.
• Reviewing and Approving Documentation: Manage the document lifecycle of Standard Operating Procedures (SOPs) and contribute to procedural changes as needed to meet GMP, corporate and regulatory requirements. Create, route and track controlled records within documents management system, Veeva. Reviewing and approving documents such as Standard Operating Procedures (SOPs), batch records, protocols, and reports to ensure accuracy, completeness, and compliance with regulatory requirements.
• Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
• Performing Audits and Inspections: Conducting audits and regulatory inspections to assess compliance with GMP and GDP requirements. Sets and manages audit schedule – collaborating with Tech Ops and internal QA to ensure audit reporting reflects current state of compliance at COs and to help address issues requiring remediation. Identifying non-conformances, implementing corrective actions, and ensuring follow-up to address audit findings.
• Managing Supplier and Vendor Quality: Assessing and approving suppliers and vendors based on their adherence to GMP and GDP standards. This involves conducting supplier audits, evaluating supplier documentation (including quality agreements), and ensuring the quality of incoming materials and products.
• Investigating Quality Issues: Investigating quality issues, deviations, complaints, and out-of-specification results to determine root causes and implement corrective and preventive actions to prevent recurrence.
• Quality Risk Management: Implementing quality risk management processes to identify, assess, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle.
• Supporting Validation Activities: Providing quality oversight and support for validation activities, including process validation, equipment qualification, analytical method validation, and cleaning validation, to ensure compliance with regulatory requirements.
• Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
• Reporting and Tracking: Providing internal customers with status reports, inspection results, improvement updates and other KPI and regulatory/quality required reporting. Provide updates to North American leadership team of progress. Manage offsite storage for all documents for the Bridgewater office, including detailed inventory and data entry into IM Connect for tracking purposes.
  
  

General Requirements

Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance principles.

Education And Experience

• Bachelor’s degree in related field, or equivalent experience required.
• Minimum of 7 years’ experience in a GxP role; Pharmaceutical experience is preferred. Experience collaborating with CMOs to obtain deliverables is recommended.
• Experience with Veeva (Quality Docs, QMS and Training modules) a plus.
• Solid understanding of GMP regulations, CFR 21 Parts 210, 211 and 600 GDP regulations USP NF1079 / USAP NF 1083
• Ability to interface with internal and external customers at all levels.
• Ability to process information quickly and correctly while maintaining a high level of customer service and communication.
  
  

Knowledge And Skills

• Intermediate knowledge of Microsoft Word, Microsoft Excel and Adobe Acrobat
• Knowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommended
• Excellent communication, organizational, interpersonal and computer skills
• Excellent Oral/Written Communication Skills
• Demonstrated ability to manage multiple competing priorities
• Solid organizational skills and attention to detail
  
  

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, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. 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.
• Minimal travel 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 accommodate for qualified individual 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.