Sr. Manager, Metrology

3 weeks ago

Raleigh, United States AAIPharma Full time

Job Summary:

The Sr. Manager of Metrology is accountable for driving results in a fast-paced environment by supervising the daily activities of the Metrology group that performs calibrations, diagnostics, repair, maintenance, and equipment qualification of laboratory analytical instrumentation such as HPLC and gas chromatography. The ideal candidate will develop production and resource plans which meet production goals in terms of safety, quality, output, cost, and financial savings for the Company. The Sr. Manager of Metrology will complete and review calibration documentation and the work of the Metrology team to ensure on time calibrations.

On-Site Expectations:

* 100% on-site position.

Responsibilities:

* Ensures adherence to personnel and equipment SOPs and other regulatory requirements.
* Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
* Makes project/work assignments with communication of the expected timeline.
* Monitors the progress against the timeline.
* Provides troubleshooting support as needed.
* Monitors the quality of the group.
* Effectively communicates with clients and internal groups.
* Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
* Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring and performance management.
* Ensures the team is meeting the required quality metrics and is able to report daily, weekly, and monthly on those metrics.
* Consistently reviews procedures and processes to ensure effectiveness and compliance with day-to-day responsibilities of the team.
* Other duties as assigned.

Qualifications:

* Bachelor's degree in Life Science, Engineering or Electronics with 8+ years related experience or AAS in Life Science, Engineering or Electronics with 10+ years' experience.
* Must have at least 4+ years of experience in leadership roles managing staff.

Knowledge, Skills, and Abilities:

* Strong mechanical skills.
* Excellent understanding of circuits, components, analytical equipment, and instrumentation for laboratory and manufacturing equipment.
* Excellent working knowledge of Microsoft Office applications.
* Strong verbal and written communication skills.
* Ability to supervise, train and mentor employees.
* Familiarity with ISO17025 red and current industry calibrations standards such as ASTM preferred.
* Basic business acumen.
* Strong understanding of company SOPs, and regulatory guidance documents.
* Strong knowledge of safety procedures and quality compliance for assigned area.
* Strong knowledge of cGMP requirements.
* Experience with client audits.
* Strong understanding of basic lab techniques.
* Strong knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
* If applicable, experience with compliance for API and drug product and/or drug substance.
* Experience with regulatory agency inspections of GXP facilities.
* Experience working with CDMOs. Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
* Good analytical and problem-solving skills, with the ability to think strategically.
* Strong attention to detail, as well as time and resource management.
* Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
* Promote a safe environment for work.
* Comply with the general policy of the company.
* High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
* Communicate well orally for internal customers and team members as well as external customers.
* Ability to write reports and business correspondences.
* Ability to listen and respond well to external customers, partners, and colleagues at all levels.
* Highly goal and result oriented.
* Can work independently with a high degree of self-motivation.
* Tackles problems with enthusiasm and curiosity.
* Treats colleagues at all levels with respect.
* Very effective listening skills with the ability to listen attentively and process information correctly.

Travel Expectations:

* 25% minimum travel.

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