Associate Director, Site Quality Systems - Albuquerque, United States - curiate

Description

Director of Quality Systems and Compliance in Albuquerque, NM.

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Director of Quality Systems and Compliance is responsible for CGMP Quality Systems and Compliance of the facility inclusive of Deviations, CAPA, Change Control, Complaints, Quality Management Review, Supplier Quality, Audits, Inspections, Document Management, Learning Management, APQR, Regulatory Affairs, and Compliance. This group is the primary Quality contact for all external and internal customers with respect to quality systems, quality process improvements, quality audits, and regulatory compliance.

This role works with internal and external customers to resolve quality issues and proactively identify areas of opportunity utilizing metrics to drive priorities. Quality Systems and Compliance works with Quality Operations to evaluate deviations related to production batches, the laboratories, and the facility. Quality Systems and Compliance is the primary Quality contact for all internal and external customer interactions with respect to Quality Systems and Compliance and supports other quality organizations (QOPS, QC, VAL) with external customer interactions.

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.

Responsibilities:

+ Lead the Quality System and Compliance program at the site including system/process owner for Deviations, CAPA, Change Control, Complaints, Quality Management Review, Supplier Quality, Audits, Inspections, Document Management, Learning Management, APQR, Regulatory Affairs, and Compliance.

+ Drive continuous improvement programs to maintain quality performance of the site. Direct quality and compliance process improvements and goals using current regulations and demonstrated best practices. Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.

+ Ensure products are manufactured per regulatory expectations and submissions. Establish and maintain robust inspection readiness program at the site. Lead internal/external audits, host regulatory inspections, and host customer audits.

+ Ensure that regulatory agency actions are monitored, both in terms of published regulations and in benchmarking of inspection trends with other companies.

+ Ensure customer relationships are managed and maintained effectively to achieve desired outcomes.

+ Manage the interface on internal quality issues, customer concerns and regulatory issues.

+ Work with internal and external customers to resolve quality issues and proactively identify areas of opportunity utilizing metrics to drive risk-based prioritization of improvement efforts.

+ Establish and report daily/weekly/monthly/quarterly/annually (as applicable) department metrics.

+ Ensure GMP areas and responsibilities are maintained in permanent inspection-ready state.

+ Ensure registrations and agency submissions are current and appropriate.

+ Ensure timely identification, investigation, correction, and resolution of deviations.

+ Develop and support departmental strategic goals to assure the highest quality standards.

+ Work with other departments to achieve site priorities, goals and objectives.

+ Mentor, coach and train department personnel to increase the level of technical skills.

+ Meet with direct reports regularly (1:1) as part of regular performance management.

+ Maintain department curriculum and training oversight for staff.

+ Establish and maintain department resource model.

+ Establish and maintain department escalation plan.

+ Establish and maintain department tier structure.

+ Establish and maintain department policies.

+ Establish and maintain department budget.

+ Other duties as assigned

Supervisory Responsibilities:

+ This job has supervisory responsibilities.

Required Qualifications:

+ Bachelor's degree in a scientific or related field from four-year college or university and minimum of ten (10) years of progressively greater responsibilities in Quality/Regulatory within pharmaceutical/medical device industries.

+ Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, and quality assurance requirements for pharmaceutical manufacturing.

+ Experience leading regulatory inspections.

+ CDMO and aseptic manufacturing experience strongly preferred.

Other Skills and Abilities:

+ Excellent Communication skills, both verbal and written.

+ Ability to organize time in order to successfully manage multiple projects and priorities.

+ Ability to read, understand, interpret and implement technical writing and instructions.

+ Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals.

+ Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.

+ Prefer knowledge in design of building management systems and cleanroom aseptic facilities.

+ Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.).

Other Qualifications:

Must pass a background check

Must pass a drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.