Your Role: The Associate Director, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations. This individual plays an …
Skills: Quality Management Systems, GxP Compliance, Team Leadership, Document Control, Change Control
Company Description You Belong Here! Today is a new day. At Asbury we’re filling it with more laughter, more possibilities, more ways to give back, all backed by support for whatever life brings your way. We are an organ…
Location: Gaithersburg, MD Hybrid: 3 days a week Make a greater impact on lives through a digitally enabled enterprise. We are working towards our aspiration of crafting the future of Pharma. Backed by investment at ever…
About the Role At Wonder, we want to make world-class food within reach, no matter where you live. As a Shift Supervisor, you are a key part of that by overseeing our kitchen operations to ensure top-notch food quality a…
Skills: Team leadership, Kitchen operations, Food quality control, Service excellence, Inventory management
Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a health tech business part of the …
At AstraZeneca, we are changing the way cancer is treated through science, innovation, and a deep commitment to patients. Our ambition in Oncology is bold: to redefine cancer care, transform outcomes, and bring life-chan…
Epic Ancillary Application Manager, Day Shift, Epic Program
Gaithersburg, Maryland, United States · On-site
$116k–$174k/yr
Senior$540K raised
Support Center If you are a current Adventist HealthCare employee, please click this link to apply through your Workday account. Adventist HealthCare seeks to hire an experienced Epic Ancillary Application Manager who wi…
Play a role in powering AstraZeneca and helping all of us to fulfil our ambitions. As valued partners across the enterprise, we provide the platform for excellence and performance to happen. We draw on our network of div…
Skills: Financial planning, Strategic leadership, Business partnering, Financial compliance, Capital expenditure evaluation
The Global Commercial Director, Hematology – Customer Engagement & Advocacy is a key member of the Global Hematology leadership and commercial teams, accountable for shaping and advancing the Franchise Customer Engagemen…
Typical Accountabilities - Execute supply and production plans to meet customer and business requirements, balancing compliance, cost, and quality considerations. - Use and maintain supply and account management informat…
Skills: Supply chain planning, SAP, Inventory management, Order processing, Forecasting
Ready to turn real-world evidence into decisions that transform cancer care? As Associate Director, Oncology Outcomes Research, you will lead high‑impact health outcomes and real‑world evidence that define the value of o…
Skills: Real-world evidence, Health economics, Epidemiology, Outcomes research, Oncology
Why Wells Fargo: Are you looking for more? Find it here. At Wells Fargo, we're more than a financial services leader – we’re a global trailblazer committed to driving innovation, empowering communities, and helping our c…
Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! Our Gaithersburg, Maryland facility creates lif…
Director, Global Oncology Policy & Advocacy (Breast Cancer & Pan Tumour)
Gaithersburg, Maryland, United States · Hybrid
$166k–$249k/yr
Senior
Director, Global Oncology Policy & Advocacy (Breast Cancer & Pan Tumour) Gaithersburg, USA Are you ready to shape the future of cancer care by turning scientific breakthroughs into system-wide change? Do you see policy a…
Individual responsibilities will include: Senior level leadership of quality oversight of commercial combination products and devicesOversee design transfer, process validation andBuild a team environment that embody’s A…
Skills: Quality oversight, Combination products, Medical devices, Design transfer, Process validation
Job Description: Global Clinical Head- Executive Director Infectious Disease Are you a clinical research expert ready for new opportunities? Would you like to play a pivotal role in the development of potential medicines…
Skills: Clinical research, Infectious diseases, Vaccines, Pharmaceutical industry, Clinical development
Summary The Manager, Enterprise Support & Technology Assets leads GeneDx’s enterprise-wide Technology support function and is accountable for the quality, responsiveness, and continuous improvement of support delivered t…
Skills: Team Leadership, Service Desk Management, ITIL, SLA Management, Asset Management
GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-s…
Sheppard Pratt is searching for a Registered Nurse to serve in a non-supervisory role as Assistant Director for its Health Home program. The position will split time between Gaithersburg and Lanham, MD. Sheeppard Pratt's…
Skills: Registered Nurse, Population Health, Care Coordination, Case Management, Behavioral Health
Are you passionate about making the world better? Are you looking for an organization that aligns with your values? MRIGlobal solves challenging problems through science, engineering, and program management. We are an in…
Skills: Business development, Pharmaceutical development, Biotechnology, Strategic planning, Relationship management
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$168k–$183k/yr
Full-time
bachelor degree
Health insurance, Vision insurance, Dental insurance, 401(k) plan
Posted 12h ago
~40 hrs/week
Responsibilities
The Associate Director leads the Quality Systems and GxP compliance operations, including document control, CAPA, and audit programs. They also mentor the QA team and serve as the primary liaison for internal and external quality system stakeholders.
Requirements
Candidates must hold a Bachelor's degree in a life science and possess over 8 years of leadership experience in biotechnology or pharmaceutical environments. Proficiency in global regulatory requirements and experience with eQMS platforms like Veeva or MasterControl are required.
Full job description
Your Role:
The Associate Director, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations.
This individual plays an integral role in ensuring internal operations, processes and systems of the Quality department are flexible, functionable, and meet phase-appropriate compliance standards. This is a cross-functional role who serves as the primary liaison to internal and external customers for all Quality system related items associated with GMP and clinical operations.
The role will serve as subject matter expert on Quality Management Systems that will help power Bioindustry technology’s continued success.
Essential Duties and Responsibilities:
Team Leadership
Lead, mentor, and develop a team of Quality Assurance Specialists through coaching, performance management, goal setting, and professional development activities.
Quality Systems & Governance
Lead Quality Systems and GxP Compliance operations, including Document Control, Training, Change Control, Deviations, OOS/OOT, CAPA, Risk Management and Product Complaint support.
Develops flexible, phase appropriate site quality systems and processes applying processes and standards in alignment with the organization’s strategy.
Build and maintain quality programs and the internal Quality Management System. Responsible for electronic QMS deployment, administration, operation, and improvement. Communicates with other departments to resolve issues, identify and close gaps, and ensure ease of use of the QMS for personnel.
Work with IT and external support services to configure the system over time as quality processes mature.
Oversee the Change Control Review Board, CAPA Review Board and Management Reviews.
Drive continuous improvement across vendor and internal quality systems, incorporating outcomes from Quality Management Review activities.
Ensure all site-related quality documentation and records are completed thoroughly and in a timely way to maintain compliance.
Vendor & Quality Agreement Management
Manage external oversight of GxP vendor quality systems.
Author, maintain, and approve Quality Agreements with GxP vendors.
Audits & Inspection Readiness
Lead internal and external GxP audit programs.
Develop an audit plan, prepare audit reports, communicate findings, audit responses, compliance gap assessments including assessment of compliance risk to support key site stakeholders.
Oversee inspection readiness activities, including mock audits and SME preparation.
Support and host regulatory inspections and client audits. Interact with regulatory agencies/clients during inspections and prepare responses using robust systems and metrics.
Drive timely and effective CAPA completion across the organization.
Review and approve OOS investigations, deviations, and product complaint investigations.
Write, review, approve, and maintain GxP SOPs and GxP policies.
Lead participation in Annual Product Quality Review activities.
Cross-Functional Partnership & Quality Culture
Provide quality and GxP compliance guidance to cross-functional partners across Regulatory, Technical Operations, and Commercial.
Ensure GxP employees complete required training.
Contribute to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement
Represent QA in internal and external meetings.
Requirements:
Bachelors in a life science from a four-year college or university; 8+ years of leadership experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP)
Demonstrated leadership experience with direct ownership of QMS and quality systems.
Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements.
Proven experience in Quality Systems Management; implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems.
Strong strategic and operational capability, balancing vision-setting with hands-on execution.
Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment.
Strong judgment and risk management skills, balancing compliance, science, and business needs.
Strong written and verbal communication skills with the ability to influence senior and cross-functional stakeholders.
Highly proactive, accountable, and comfortable operating with a high degree of autonomy.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.
The anticipated base salary range has been established at $167,780 - $182,548/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.
Miltenyi Biotec, Inc., is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Miltenyi Biotec, Inc. participates in E-Verify.
The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.
Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.
For over 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 5,000 experts from over 75 countries contribute to our sustainable success.
Offices: Friedrich-Ebert-Straße 68, Bergisch Gladbach, North Rhine-Westphalia 51429, DE · 2303 Lindbergh Street, Auburn, CA 95602, US · Robert-Koch-Str. 1, Teterow, Mecklenburg-Western Pomerania 17166, DE · Astastraße 14, Bielefeld, North Rhine-Westphalia 33617, DE · Bertha-von-Suttner-Str. 5, Göttingen, Lower Saxony 37085, DE
How much do Management & Leadership jobs in Gaithersburg, MD pay?
Based on 226 listings with disclosed salaries, most management & leadership jobs in Gaithersburg, MD pay between $54k–$241k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Gaithersburg, MD right now?
There are currently 271 open management & leadership positions in Gaithersburg, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Gaithersburg, MD?
Companies currently hiring include AstraZeneca, Adventist HealthCare, Asbury Communities, Inc., BAYADA Home Health Care, Five Below, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Gaithersburg, MD?
Yes — 84 of the 271 open management & leadership positions offer remote or hybrid work (4 remote, 80 hybrid).
How do I apply for Management & Leadership jobs in Gaithersburg, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.