Sr. Director, Quality

Sr. Director, Quality page is loaded## Sr. Director, Quality locations:
USA - NC - Durham - Hamlin Rdtime type:
Full time posted on:
Posted Yesterday job requisition :
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** Job Summary
** Senior Director of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. Lead a Quality Assurance and Quality Control team which includes both QC Analytical and QC Microbiology. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.
** Quality Assurance
** The Senior Director of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement.

Partner with Global Quality in ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site.
** Quality Control
** The Senior Director of Quality, Quality Site Head is accountable for QC Analytical and QC Microbiology. He/she is responsible for oversight of QC Analytical testing. He/she is responsible for oversight of QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management.  Proven skills in the knowledge of 21

CFR
210, 211 is also required.

This role is key in collaborating with site operations (Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Operations and Site Head is crucial to ensure the site’s  consultation with the SVP of Quality and Regulatory, the Senior Director of Quality, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.
** Responsibilities:
*** Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives.
* Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
* Key contributor to long term strategic planning and part of senior leadership team.
* Work with internal and client teams to establish Quality strategy, define roles, and problem solve.
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* Minimum Requirements:

** Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required. A Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered. At least 15 years of regulated pharmaceutical industry experience.

CMO experience preferred.

Must have thorough knowledge of cGMPs and biotechnology-derived product regulations. Also requires a demonstrated track record in the following key areas:
* Regulatory Inspection management
* Strong orientation for Quality and Customer Service
* Strong collaboration and team building skills
* Support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies
* Demonstrated level of respect for individuals
* High level of integrity and personal responsibility
* Record of innovation
• Experience developing, implementing, and executing strategic plans and objectives for organizations and departments
** Must have:
*** Ability to…