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Director, Global Quality Compliance in Albany, NY at AMRI

Date Posted: 12/4/2018

Job Snapshot

Job Description

SUMMARY OF FUNCTIONS
The Director, Global Quality Compliance: Develops and provides guidance for the implementation of quality and regulatory compliance standards at the global GMP sites, to ensure compliance with applicable agency regulations (e.g., FDA, DEA, EMA, MHRA), regulatory guidances, and AMRI corporate objectives; Coordinates and provides oversight for compliance harmonization and continual improvement initiatives at the global GMP sites.
MAJOR DUTIES AND RESPONSIBILITIES
 
- Serve as a quality and compliance expert for API, DP, and DDA business units.
- Drive quality/compliance harmonization and continual improvement initiatives. Anticipate future industry requirements and technologies, and build plans to integrate at AMRI.  
- Coordinate and oversee regulatory inspection/audit readiness activities at the global GMP sites. Assist in the review of regulatory audit responses, as needed.
- Coordinate/perform periodic audits, risk assessments and gap analyses at global GMP sites to identify opportunities for improvement (gap analysis) and to support remediation efforts.
- Coordinate/perform corporate audits of global AMRI sites to support mutual recognition within AMRI (e.g., Demonstrate control in the transfer of materials and services between AMRI sites; Provide evidence of site inspection for QP release of batches to EU).
- Develop and/or review quality standards, policies, and procedures and support/monitor their implementation at global GMP sites (e.g., data integrity, sterility assurance).

- Maintain repository for regulatory inspection documents (audit reports, EIRs, responses) and metrics for global GMP sites. This includes the regulatory inspection summary and classification of observations for presentation to AMRI site and executive leadership.

- Escalate critical or repeated observations from inspections/audits or serious compliance gaps to appropriate Quality leadership.

- Lead training initiatives on quality/compliance topics to the global GMP sites. Partner with the site compliance leaders and SMEs to ensure broad understanding and interpretation of relevant issues. 

- Participate in self-development activities to stay updated on the most current expectations by regulatory agencies and industry best practices.

- Perform other duties as may be reasonably assigned in the course of business.



 SUPERVISORY RESPONSIBILITIES

 This position has supervisory responsibilities.

Job Requirements



QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Education and/or Experience
  • Minimum Bachelor of Science degree in Chemistry or a related field
  • Minimum 10 years QA, RA, or Compliance experience in pharmaceutical industry at US FDA regulated facilities
  • Broad knowledge of US and international cGMP regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7)
  • Knowledge of pharmaceutical manufacturing and service-provider compliance processes.
  • US FDA/EU inspection experience (participating or leading)
  • Auditing experience is preferred.
  • Prior supervisory experience in a pharmaceutical, CRO/CDMO environment
  • Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
  • Proficient in building consensus, negotiating and escalating issues
  • Good understanding of the importance and use of quality metrics

Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.