What are the responsibilities and job description for the Manager - Quality Assurance Operations (Contractor) position at Advantage Technical?
Job Title: Manager - Quality Assurance Operations (Contractor)
Location: Remote (East Coast preferred, hybrid for local candidates)
Experience Required: 5-7 years
Overview:
We are seeking a Manager of Quality Assurance Operations to join our DP/CMC/Alliance QA Operations team. This contractor role is focused on providing support for all GMP aspects of drug product (DP) manufacturing, CMC, and alliance management. The position requires a hands-on approach to operational quality oversight, ensuring compliance with cGMP regulatory requirements from clinical through commercial lifecycle activities. This role reports directly to the Director of Quality Assurance.
Key Responsibilities:
- Oversee quality processes for external manufacturing of clinical and commercial drug products, including lot disposition.
- Review and approve Deviations, Change Controls, and CAPAs for both internal and external operations.
- Provide QA support for review and data verification in clinical regulatory filings.
- Collaborate with alliance partners to ensure compliance with quality systems and practices related to drug product manufacturing and disposition.
- Establish and promote best practices in partnership with internal teams and external vendors.
- Resolve complex quality issues through compliant, patient-centric solutions.
- Monitor and report timely, accurate metrics for KPI tracking and risk register management.
- Drive continuous improvement initiatives to mitigate risks and enhance operational effectiveness.
Qualifications:
- Bachelor's degree in life sciences, engineering, or a related field.
- 5 years of experience in pharmaceutical or biopharmaceutical Quality Assurance roles with increasing responsibility.
- Proven experience working with external Contract Manufacturing Organizations (CMOs) in a virtual setting.
- Knowledge of aseptic techniques and parenteral drug manufacturing operations.
- Hands-on GMP management experience, including exposure to FDA, EMA, PMDA, ANVISA, or similar regulatory authorities.
- Familiarity with investigational and commercial products in a Quality Operations role is preferred.
- Experience collaborating with Alliance Partners is a plus.
- Demonstrated ability to streamline processes and improve turnaround times.
- Proficiency in Veeva Quality and SAP is essential.
If you are a detail-oriented professional with a passion for maintaining high-quality standards in pharmaceutical operations, we encourage you to apply today!
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About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
