Senior Quality Specialist

OVERVIEW

- Quality person with 5-8 years minimum experience in:
- Pharma/Biopharma
- GMP/GLP
- Quality systems
- Dealing with manuals
- Compliance

ESSENTIAL FUNCTION(S) INCLUDES, BUT IS NOT LIMITED TO:

The SWr. Quality Specialist small/Large Molecules, AH Quality systems Compliance reports to the Director, Animal Health Quality systems and Compliance, and supports all Quality Systems Compliance activities relating to the SMIM regions across the AH Line of Business to ensure compliance with all AHQM documents as well as applicable regulations and specifications.

PRIMARY ACTIVITIES INCLUDE, BUT ARE NOT LIMITED TO:
Partner with the Global SO and SSO for chapters to proactively identify initiatives and AHQM enhancements. Serve in the role of administrator to ensure a continuous improvement mind-set for the AHQM documents. Support Tier III roll out to SM LM sites and relative training in my Leaming
Assist in various programs across sites as identified by the AH SMLM, including, but not limited to

- Ensure that Animal Health Quality Bulletin is deployed through all SMLM sites, ensure its effectiveness, support site variances and ability of site to maintain level of compliance Confirm closure of activities according to plan Support sites on implementation of relevant Quality Alerts and Quality Bulletins.
- Partner with the Global SO and SSO for chapters to proactively identify initiatives and AHQM enhancements. Serve in the role of administrator to ensure a continuous improvement mind-set for the AHQM documents. Support Tier III roll out to SM LM sites and relative training in my Leaming
- Assist in various programs across sites as identified by the AH SMLM, including, but not limited to
- Quality and Compliance Excellence(QCE), in particular,
- Support Global SO and SSO for periodic review of the system
- Inspection Readiness Masterplan and review with Site prior to planned inspection, and responses
- Support sites for Divisional audit and responses
- Support and contribute to internal compliance forums to identify any emerging trends for continuous improvement in the SM/LM region related to Quality Systems requirements These activities include:
- Support and contribute to internal compliance forums to identify any emerging trends for continuous improvement in the SM/LM region related to Quality Systems requirements These activities include:
- Support and contribute to internal compliance forums to identify any emerging trends for continuous improvement in the SM/LM region related to Quality Systems requirements These activities include:
- Driving improvements from significant investigations and/or current compliance trends within both SM and LM regions
- Support QSC as expert for SM/LM in review of AHQM policies and procedures linked to MMMD policies and guidelines, and providing perspective of QSC to sites.
- Prepare AHQM policies and procedures once required in the area of Quality Management together to the Director, AH Quality systems Compliance.
- Partner with the SMLM sites, to ensure the overall compliance posture for the AH SM/LM is resilient and sustained.

REQUIRED EXPERIENCE:

- Bachelor's degree in an appropriate scientific or engineering field of study is required.
- Preferred fields of study include Biology, Biochemistry and Microbiology.
- An MBA or other business degree in addition to the required science or engineering education, is a plus.
- At least eight (realistically 5) years of work experience in a pharmaceutical biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field. Strong understanding of cGMPs, GLPs, FDA, EU, USDA and EPA regulatory standards.
- Strong compliance mind-set
- Strong lean mind set with MPs Kata capabilities.
- Ability to work within a Matrix organization to align on expectations and resolutions