AbbVie

Aseptic Product Quality Associate Director

AbbVie • $120K — $150K *
Worcester, MA 01604In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Life Science or related field; graduate degree preferred.
  • 10+ years of experience in Quality Assurance or Regulatory roles within pharmaceuticals.
  • In-depth knowledge of pharmaceutical technologies including sterile and biological products.
  • Strong analytical skills and aptitude for problem-solving in high-pressure environments.
  • Experience with third-party external manufacturing requirements.

Responsibilities

  • Lead aseptic strategies to ensure robust product quality assurance in Eye Care.
  • Conduct due diligence visits to evaluate prospective external partners.
  • Perform assessments of aseptic manufacturing processes and implement best practices.
  • Provide leadership for aseptic investigations, including root cause analysis and corrective actions.
  • Monitor emerging technologies and industry trends affecting aseptic manufacturing.
  • Oversee external operations to ensure compliance with regulatory standards and quality assurance.
  • Collaborate with internal and external stakeholders to enhance quality processes.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan for eligible employees.
  • Paid time off including vacation, holidays, and sick days.
  • Eligibility for long-term incentive programs.
Full Job Description
Job Description

The Aseptic Product Quality, Associate Director serves as the quality subject matter expert for aseptic manufacturing within the External & Product Quality Assurance Eye Care Global Team. This role provides quality leadership in support of due diligence activities at third-party manufacturers (TPMs/CMOs) and contributes as a key member of cross-functional teams.The Associate Director is responsible for performing aseptic assessments, supporting aseptic-related investigations, and advancing the implementation of best practices across the external manufacturing network. The role also evaluates aseptic standards across internal and external operations, while maintaining awareness of evolving technologies and industry practices .In close partnership with TPMs/CMOs and internal stakeholders, this position drives continuous improvement through the proactive identification, assessment, prioritization, and mitigation of aseptic risk. The role also fosters strong collaboration across AbbVie manufacturing sites, global aseptic teams, and cross-functional partners to strengthen quality oversight and ensure alignment across the network.

Responsibilities
  • Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies that ensure robust product quality assurance.
  • Conduct due diligence visits to prospective external partners (TPMs/CMOs) as a member of cross-functional teams.
  • Perform hands-on assessments of aseptic manufacturing operations, processes, and controls, while driving the implementation and adoption of aseptic best practices across external partners to strengthen quality systems and operational performance.
  • Provide technical quality leadership for aseptic-related investigations, including root cause identification, risk evaluation, and the development of corrective and preventive actions.
  • Monitor and evaluate emerging technologies, regulatory expectations, and industry trends related to aseptic manufacturing and contamination control.
  • Provide quality oversight of external manufacturing operations to ensure compliance with applicable regulatory requirements and quality standards, while proactively identifying, assessing, prioritizing, and mitigating aseptic risks.
  • Deliver strategic input and recommendations to support risk-based decision-making for aseptic manufacturing and external quality operations.
  • Build and sustain collaborative relationships with AbbVie internal manufacturing sites, global aseptic teams, and cross-functional stakeholders.
  • Support the escalation, communication, and resolution of significant aseptic quality issues that may affect product quality or supply continuity.
  • Foster and promote a strong quality culture centered on proactive risk management, continuous improvement, product quality, and operational excellence


Qualifications
  • Bachelor's Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
  • Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
  • Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals.
  • Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
  • A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
  • Experience working the requirements for third party external manufacturing.


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The 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 posting based 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 or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our long-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 paid and 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
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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