Senior Director- Quality Operations

AmerisourceBergen; Columbus (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative company is seeking a Quality Assurance Leader to drive compliance and quality systems within the pharmaceutical industry. This role involves leading teams, ensuring adherence to regulatory standards, and fostering a culture of collaboration and continuous improvement. You will be pivotal in overseeing quality investigations, supplier compliance, and operational quality, ensuring the organization is always prepared for inspections and audits. If you are passionate about quality and compliance and want to make a significant impact in health care, this opportunity is for you.

Benefits

Medical Insurance

Dental Insurance

Vision Care

Paid Parental Leave

Professional Development Resources

Mentorship Programs

Volunteer Activities

Backup Dependent Care

Infertility Coverage

Behavioral Health Solutions

Qualifications

• 10+ years in pharmaceutical/medical device manufacturing.
• Experience with CAPA, FDA/DEA regulations, and Quality Assurance.

Responsibilities

• Lead Quality Operations and ensure compliance with regulatory requirements.
• Develop and maintain Quality Assurance systems.

Skills

Leadership

Problem Solving

Root Cause Analysis

Communication Skills

Organizational Skills

Regulatory Compliance

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Under the general direction of the Vice President, Quality Systems and Regulatory Affairs, responsible for developing, revising, and maintaining Quality Assurance systems to ensure compliance with cGMP, FDA/DEA regulations, and corporate policies.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division corporate and government regulatory requirements. It is the associates responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

• Directs, leads, trains, and mentors the broader Quality Operations functions: Quality Investigations, CAPA, Supplier Quality, Production Quality, Warehouse Quality.
• Actively develops leaders and instills a culture of collaboration with a focus on solutions.
• Sets departmental objectives for strategic alignment to site goals within the Quality Systems and Regulatory Affairs function.
• Promotes Quality Assurance principles throughout the facility to assure site is always ready for regulatory inspections and corporate audits.
• Serves as primary point of contact for DSCSA and serialization compliance requirements.
• Represent AHP Quality on select corporate teams, as needed.
• Functions as delegate of VP, Quality Systems and Regulatory Affairs.
• Assumes Quality Assurance oversight of the change control, validation, and operational activities.

• Quality Investigations/CAPA: Guides team members and prioritizes workload to meet regulatory mandates and business objectives.
• Ensures all investigations are conducted within applicable requirements.
• Supplier Quality: Oversees qualification of suppliers and service providers to assure compliance to AHP expectations, cGMP requirements, and applicable regulations.
• Operations/Warehouse Quality: Directs broader Quality team to ensure packaging and distribution remains compliant.
• Oversight of product disposition to include final approval/rejection of finished products, rework items, and materials under investigation.
• Approves and assumes ownership of departmental SOPs and Work Instructions for all downstream processes.
• Responsible for developing quarterly management reviews on investigation trending.
• Assures all associates follow cGMP and safety procedures.
• Ability to develop and maintain cooperative working relationships
• Ability to handle a variety of tasks simultaneously
• Good verbal and written communication skills
• Performs related duties as assigned

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

A minimum of 10 years’ experience leading and directing the work of others in a pharmaceutical/medical device manufacturing industry.

Five years of leading teams and/or management experience.

Requires a bachelor’s degree or equivalent combination of experience and education.

Experience with Pharmaceutical Investigations, Corrective and Preventive Action (CAPA), Deviation management, Root Cause Analysis tools, cGMP documentation, and Quality Assurance.

Knowledge of FDA and DEA regulations required.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Ability to lead and manage individuals
• Strong data-driven problem solving and root cause analysis skills are required Proficient in Microsoft Office applications (Word, Excel)
• Possess strong organizational skills for prioritizing workload and responsibilities Ability to handle multiple projects
• Must be able to work in a fast-paced environment and deliver projects and requests on time with respect to established timelines

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies Affiliated Companies: Amerisource Health Services, LLC