Manager, Manufacturing Quality Assurance
CuriaAbout the role
Manager, Manufacturing Quality Assurance in Albuquerque, NM
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Manufacturing Quality Assurance (MQA) Manager leads all activities related to daily product manufacturing and lot release. As the primary Quality contact for internal teams, the MQA Manager spearheads initiatives to resolve product, process, and material issues. Key responsibilities include directing manufacturing quality operations, overseeing in-process and final product inspections, managing batch record reviews, supporting validation efforts, and addressing customer batch release queries. The role ensures that all products consistently meet regulatory, corporate, and customer standards for quality, safety, and efficacy.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
We proudly offer:
- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401k program
- Learning platform
- And more!
Responsibilities:
- Direct and manage the Manufacturing Quality Assurance activities, to include on the floor batch record review and 24/7 Quality Assurance oversight of manufacturing processes.
- On call to answer quality questions from Quality Assurance and Production employees as needed.
- Provide manufacturing and Quality Assurance technical expertise to internal departments.
- Provide training on cGMPs to the QA group and Production as needed.
- Provide support on validation report closure, change control, investigation approval and other QA systems related issues.
- Direct and manage strategic/global projects by working with all plant management groups on new products, changes to products, and services to achieve a consistent approach to Quality as needed.
- Support quality and compliance process improvements and goals for the sites using current regulations and best-demonstrated practices as needed.
- Direct effective and efficient continuous quality and cost improvement efforts as needed.
- Hire, train and develop MQA staff and conduct Performance Reviews to assure highly effective, team-oriented contributors.
- Develops and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
- Serves as resident QA expert in support of all manufacturing quality assurance functions (product release, product inspection, batch record reviews, compliance) and resolution of issues on the production floor
- Read/interpret SOPs to ensure compliance
- Maintain up to date trainings
- Other duties as assigned
Education and/or Experience:
- Bachelor’s degree in in Science, Chemistry, Biology or related field of study
- Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management
- Minimum of two (2) years in a leadership role
- Minimum of five (5) years in an aseptic/sterile product facility. Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.
- Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred
- Minimum of 10 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience, preferred
Supervisory Responsibilities:
This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.
Other Skills and Abilities:
- Leads with integrity and respect
- Provides guidance, coaching, and mentorship to team members
- Demonstrates business acumen
- Fosters a co
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