Associate Clinical Quality Assurance (QA) Director
Company: MacroGenics, Inc.
Posted on: September 14, 2023
Associate Clinical Quality Assurance (QA) Director MacroGenics
is a leader in the discovery and development of innovative
medicines that utilize our next generation antibody-based
technologies. Our team of -350+ dedicated individuals is advancing
a pipeline of product candidates to treat patients with cancer.Our
products and platforms have attracted multiple partnerships with
leading pharmaceutical -and biotechnology -companies around the
globe. -MacroGenics is a bold, highly engaged, and diverse team
driven by a passion for improving the lives of patients through
innovative science. We are committed to an inclusive workplace
built on trust and respect. We value and nurture strong connections
with one another and foster collaborative relationships. We empower
our people and drive personal accountability. We encourage
curiosity and -embrace our entrepreneurial spirit. We celebrate our
successes and create a learning environment where all employees can
thrive! -Summary of PositionAs Associate Director, Clinical Quality
Assurance you will apply your established knowledge of GCP guidance
and regulations to lead Clinical Quality Assurance activities for
assigned clinical development programs. Also responsible for
overseeing and executing the assigned audit plans and strategies on
assigned programs, and ensuring GCP compliance by working
proactively and cross functionally with Clinical Operations
- Oversee the development, implementation, and continuous
improvement of Clinical Quality Management System, ensuring
compliance with industry standards, regulations, and best practices
on assigned audit plans.
- Manages and/or conducts the planning, execution and resolution
of risk-based investigator site, vendor and internal system audits
of MacroGenics processes.
- Evaluates audit responses, as well as routinely monitors
established quality and performance metrics to identify potential
quality related trends or areas of regulatory risk. Makes
recommendations for resolution and/or escalates, as appropriate to
- Manages study level risk assessments to proactively identify
and mitigate significant compliance risks.
- Facilitates the development and maintenance of all processes,
procedures, and systems relate to clinical trial activities for all
Clinical Development functional areas to ensure compliance with
applicable regulations and the MacroGenics quality system
requirements. Identifies any areas of concern, develops proposals
for action plans, and drives solutions where possible. Raises
unresolved issues with Quality senior management if necessary.
- Provides consultation regarding recently released health
authority regulations or guidance, as well as topics of current
regulatory emphasis to MacroGenics clinical study teams and/or
relevant clinical functional areas. Viewed as an expert in this
- Designs and conducts annual GCP training programs for Clinical
- Performs other Clinical QA duties as
assigned.QualificationsEducation & Credentials
- Bachelor's degree. Life Sciences field of study preferred.
Equivalent experience will be considered in lieu of a
- Minimum of nine (9) years pharmaceutical/biotech clinical
research or clinical operations experience
- Minimum of five years of GCP auditing experience
- Experienced in developing and providing GCP training to a wide
range of audiences
- Experience with international clinical trials Knowledge, Skills
- In-depth knowledge of FDA and ICH GCP regulations, guidelines
and industry best practices.
- Keen awareness of the practical application of these GCP
- Demonstrated ability to respond to inquiries from regulatory
- Ability to effectively present information cross-functionally
and to management.
- Ability to write effective audit reports.
- Strong knowledge of MS Word, Excel, PowerPoint & Outlook.
- Excellent communication, analytical, and organizational
- Working knowledge of GLP, and/or GMP guidelines and
- Strong attention to detail
- Must be able to manage competing priorities and meet
- Able to travel at least 50% of the time, both domestic and
international.Supervisory -Responsibilities -
-NoneStatementMacroGenics is proud to be an equal opportunity
employer. Employment selection and related decisions are made
without regard to race, color, national origin, sex, gender
identity, sexual orientation, religion, age, disability, protected
veteran status, or any other characteristic protected by federal,
state or local law. We are committed to working with and providing
reasonable accommodation to individuals with disabilities. If,
because of a medical condition or disability, you need a reasonable
accommodation for any part of the employment process, please email
email@example.com or call (301) 354-3566 and/or 711 for TTD/TTY
service. -Equal Opportunity Employer/Veterans/DisabledWe do not
accept non-solicited resumes or candidate submittals from
Keywords: MacroGenics, Inc., Rockville , Associate Clinical Quality Assurance (QA) Director, Executive , Rockville, Maryland
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