Manager, Quality Control Laboratory

Posted 6 Days Ago
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Waco, TX, USA
In-Office
Expert/Leader
Healthtech • Pharmaceutical
The Role
Lead the site Quality Control laboratory and ensure QC/QA compliance across the manufacturing site. Manage lab staff, budget, and lab systems (Maximo); oversee raw material/ERP approvals, ER/CAPA investigations, protocol qualification/validation, audits, regulatory inspections, and quality-related projects and metrics.
Summary Generated by Built In
Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.

Responsibilities

  • Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
  • Member of the Laboratory Center of Excellence (COE)
  • Serves as the standalone laboratory systems and site Maximo administrator
  • Reviews and approves raw materials and commodities including ERP approval
  • Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
  • Qualification and validation protocol writing, review, and approval
  • Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
  • Provides front room and laboratory SME support during regulatory agency and internal inspections
  • Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
  • Leads the implementation of Quality-related projects including metrics

Qualifications

  • Bachelor’s degree with 10 years of pharmaceutical Quality experience (preferably in QC) or an equivalent combination of education and experience

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 thisposting 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 anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Skills Required

  • Bachelor's degree or equivalent
  • 10 years of pharmaceutical quality experience
  • Experience managing a QC laboratory and staff
  • Experience with CAPA, ER investigations, and writing effective corrective actions
  • Qualification and validation protocol writing and review experience
  • Experience supporting regulatory inspections and internal audits
  • Experience as laboratory systems and Maximo administrator
  • Experience with ERP approvals for raw materials and commodities
  • Preferably QC-specific pharmaceutical experience

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
  • Parental & Family Support Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
  • Healthcare Strength Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.

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The Company
HQ: Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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