Manager, Product Compliance (Complaints)

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 106,000 - 203,000; Full time

Job summary

A leading company in pharmaceuticals is seeking a Manager, Product Compliance to lead a team specializing in quality assurance and complaint management. This role requires strong interpersonal and problem-solving skills, oversight of QA operations, and collaboration across functions to ensure regulatory compliance. The candidate should possess a Bachelor's degree in a scientific field and have extensive management experience. Inclusivity and diversity are core to the company’s culture, offering comprehensive benefits.

Benefits

Comprehensive health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• 7+ years experience for Manager level.
• Experience with third-party vendors is beneficial.
• Knowledge of GxP, ISO, ICH regulations required.

Responsibilities

• Manage complaints operations and triage external complaints.
• Train staff and user departments on product complaints.
• Ensure inspection readiness for complaint related items.

Skills

Interpersonal Communication

Negotiation

Technical Problem-Solving

Creativity

Education

Bachelor's degree in a scientific subject area

Tools

MS Project

Excel

PowerPoint

Word

Job description

The Manager, Product Compliance (Complaints) leads a team ensuring quality assurance and compliance in handling returned product complaints, external complaint management, and regulatory retain examinations. This role involves oversight of daily QA operations, documentation, SOPs, and cross-functional team collaborations with functions such as Manufacturing (Internal & External), QC, QA, and Global Patient Safety while aligning with regulatory requirements and site standards.

In this role, a typical day might include the following:

• Manage tasks specific to complaints operations including triaging external complaints

• Prepares status reports for management

• As appropriate, trains staff and user departments in Product Complaint items

• Reviews/Approves product complaints files

• Communicate with personnel and contractors across sites and externally (partners, vendors, Tarrytown)

• Develop and Conduct trainings with outside vendors

• Ensure Inspection readiness for complaint related items

• Participate as SME for area during inspections/audits as needed

• Plan, schedule, and guide team to ensure compliance

• Identify gaps in systems and develop feasible plans for corrections

• Facilitating continuous improvement initiatives specific to function.

• Ensuring appropriate training programs are implemented related to function

• Apply knowledge of regulatory requirements to identify reportable events when received and provide support of decisions

This role might be for you if:

• You have strong interpersonal communication, negotiation, technical, and problem-solving skills

• You exhibit a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment

• You understand and listen to team members and partners while encouraging a productive team environment to one common project objective

• You are committed to proactive resolution of project related issues with tact, subtlety and composure

• You show resiliency and flexibility in the face of challenges and adversarial situations

• You are able to provide clear direction to others in ambiguous situations and environments

• You possess knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.)

• Experience handling third party vendors and partner relationships

• You apply technical expertise (in your area) and may contribute to the development of new concepts, techniques and standards

• You are proficient in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments

To be considered for this role, you must hold a Bachelors degree in a scientific subject area or related field and the following years of experience for each level:

• Manager: 7+ years

• Sr Manager: 8+ years

Level is determined based on qualifications relevant to the role. Equivalent combination of education and experience may be considered.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$106,400.00 - $203,000.00