AbbVie

Senior Manager, Product Development Quality Assurance (CMC Product Lead)

AbbVie$120K — $150K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences (biology, chemistry, or engineering) or equivalent experience.
  • Preferred Master's degree, commensurate with experience.
  • 8+ years in Quality Assurance, production, testing, or drug development; less with an advanced degree.
  • In-depth knowledge of pharmaceutical manufacturing processes and global GMP requirements.
  • Experience in project management; PMP certification preferred but not necessary.
  • Strong leadership and communication skills are essential.
  • Ability to effectively solve complex technical and quality issues.

Responsibilities

  • Provide oversight and timely communication on program strategies for the RDQA QA organization.
  • Act as the QA representative for CMC product development teams to ensure timely drug approvals for clinical trials.
  • Lead cross-functional process improvement teams on a global scale.
  • Develop innovative, risk-based solutions to complicated technical challenges.
  • Prepare for regulatory inspections and internal audits, representing Quality during these processes.
  • Review and approve high-impact exception reports affecting multifunctional areas.
  • Manage actions related to clinical supply products and recalls ensuring compliance.
  • Support in-licensing and collaboration projects, ensuring quality agreements are established with external partners.
  • Influence decisions among R&D leadership and mentor team members.

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) options.
  • Eligibility for short-term incentive programs.
Full Job Description
Primarily responsible for supporting AbbVie's pipeline, by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners. Responsibilities List up to 10 main responsibilities for the job. Include information about the accountability and scope. 37Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management. 37QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines 37Lead complex global cross-functional process improvement teams. 37Provide innovative and risk-based solutions to complex technical problems. 37Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits. 37Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas. 37Provide management of clinical supply product actions and recalls. 37Support in-licensing and collaboration activities. 37Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites. 37Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff. Qualifications 37Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience. 37Master's degree is preferred but is not required based on commensurate experience. 378+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree. 37Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred. 37Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required. 37Strong leadership, communication, and organizational skills. 37Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 37The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. 37We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 37This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

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AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

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