1 Director of Quality Management Systems Job in Hunt Valley, MD
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Director of Quality Management Systems
$167k-205k (estimate)
Full Time | Pharmaceutical
5 Days Ago
PII is Hiring a Director of Quality Management Systems Near Hunt Valley, MD
Job OverviewThe Director of Quality Management Systems ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Systems (Change Controls, Complaints, CAPAs, Investigations and Supplier Quality) and Compliance in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.
Responsibilities
Responsibilities
- To execute and drive the site's quality policies and procedures, evaluate and where needed contribute to its continuous improvement.
- To lead quality assurance oversight of operations performed within the site, such as quality systems & compliance.
- To lead, support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs.
- To drive the timely closure of general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, and reporting of quality metrics.
- To ensure that the site's quality standards, practices, procedures, and documentation are in accordance with regulatory, pharmacopoeia! and company requirements as well as industry standards and best practices.
- To support regulatory and customer inspections and to maintain a state of inspection readiness.
- To lead, monitor, manage and drive continuous improvement of site Quality KPl's.
- To sponsor and manage QA related projects.
- To review and approve quality system documents to ensure that they comply with relevant SOPs, are GMP compliant and meet regulatory requirements.
- To help remedy compliance issues appropriately when identified.
- Respond to external customers.
- To lead or participate in meetings to direct others, or to report on, contribute to and/or resolve quality related matters.
- To represent QA and provide QA related expertise in various internal/external meetings.
- To monitor training completion and ensure both personal and departmental training status remains current.
- Lead team members and activities in respective areas as required.
- Perform other duties as assigned.
- Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Master’s degree or higher, in Life Sciences, Pharmacy, Engineering, Industrial Management, Operations, Quality is preferred.
- Minimum of 1O years relevant work experience in Quality Assurance or in combination with relevant education/experience.
- 5 years of leadership experience
- Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
- Strong experience with project and people management.
- Able to administer personnel performance evaluations.
- Demonstrate the ability to write and understand technical information and produce detailed reports.
- Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate the ability to effectively train others on programs and procedures.
- Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$167k-205k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
07/10/2024
WEBSITE
pharm-int.com
HEADQUARTERS
COCKEYSVILLE, MD
SIZE
200 - 500
FOUNDED
1994
CEO
KHURSHID KAZMI
REVENUE
<$5M
INDUSTRY
Pharmaceutical
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