We are currently looking to fill a Senior Quality Compliance Specialist for Change Control Partner Relations on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to facilitate partner activities and relationships regarding change controls
As a Senior Quality Compliance Specialist, a typical day might include the following:
- Meeting with external Partners to discuss changes for applicable products
- Maintaining internal databases and tracking of change notifications
- Partnering with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures
- Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification
- Developing, monitoring, and communicating metrics to ensure the health of the partner notification process
- Partnering with counterparts to ensure global alignment of processes, systems, and procedures
- Partnering with colleagues in other departments on strategies to ensure changes to not impact supply
- Assisting as needed in audits and inspections
- Review and Approval of Change Proposals as required
This role might be for you if:
- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
- Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
- Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
- Consistent record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
- Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
- Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred
To be considered for this role, you must hold a Bachelor’s in a scientific or engineering subject area or related field and:
- 3+ years experience for Specialist in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
- 8+ years experience for Senior Specialist in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
- Experience in change control function strongly preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.