Novartis Hiring for Senior Document Control Specialist job in Millburn Full Time

The Site Senior QA Compliance Specialist Document Control is responsible for oversight of the local quality systems governing manufacturing, testing, and supply chain operations to ensure compliance with current GMP regulations, Novartis and AAA processes, procedures, and quality systems, and all applicable health authority regulations and guidelines.

Generally, all QA Compliance Management are responsible for supporting all of the functions and activities of the QA Compliance department. Specifically, the site QA Compliance Management for document control is accountable for the management and administration of the AAA Millburn Document Control systems.

Responsibilities to include, but not limited to:

•Lead the programs for issuance, maintenance, periodic review, and archival of logbooks and other controlled records for the site
•Manage the physical and electronic document archives, primarily responsible for logging, scanning, and retrieval.
•Oversee Iron Mountain activities for the site, including off-site document storage, “true copy” scanning, and shredbox maintenance
•Become the site SOP Manager, with responsibilities in AAA ENNOV and Novartis D2 ESOPS electronic document repository systems
•Support site implementations and migrations from ENNOV to other Novartis electronic repositories, specifically: DocStore CONDOR (Controlled Documents) and SUBWAY (Registered Submission Documents), D2 ESOPS (Procedures & Forms), and Up4Growth (Training)
•Primary site contact, along with the department head, for the AAA Corporate SOP Integration program
•Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance.
•Provide backup support for other QA Compliance Management members, as needed

The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.What you’ll bring to the role:

•Bachelor’s Degree in a scientific or health related field preferred.
•Direct experience in the job functions in lieu of a degree is acceptable for this position

•4+ years of relevant GMP work experience
•3+ years of documentation control experience
•Thorough knowledge of GMP and Good Documentation Practices
•Strong organization, team leadership, and problem-solving skills
•Strong personal ethics and responsibility
•Digital & technology savviness
•Excellent and effective interpersonal and communication skills

Preferred:
•4+ years of experience in Quality Assurance/Compliance, or documentation control
•QA, QC, and/or Production experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones. Experience with radiopharmaceuticals is a +
•Practical experience in establishing and maintaining quality systems, as well as successfully supporting Health Authority inspections from e.g.: USA, EMEA, Canada, Japan, Brazil
•Track record of fostering collaboration and alliance across internal departments
•Experience conducting quality investigations, root cause analyses, and quality risk assessments
•Proven ability to assess quality needs and gaps and propose compliant solutions to them

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.