Director, Quality Assurance
Company: Cambrex Corporation
Location: High Point
Posted on: February 15, 2021
At Cambrex, it's our people that set us apart. We work locally
and have an impact globally. We're committed to attracting,
nurturing and retaining a passionate and talented team of experts
in our fast paced and growing company. You will be valued and
recognized. We offer an exceptional benefits package including
medical, dental, vision, Life, STD, LTD, generous vacation in your
first year, sick time, and retirement savings! Cambrex is the small
molecule company that provides drug substance, drug product and
analytical services across the entire drug lifecycle. Known for our
scientific and manufacturing excellence and customer focus, we
offer a range of career opportunities across our global network of
locations. As a team, we share one goal - to improve the quality of
life for our customers' patients across the world. Cambrex
(www.Cambrex.com) is seeking a highly motivated, energetic,
results-oriented individual to lead our QA team of dedicated
professionals focused on customer service and quality. We are
currently accepting resumes for the position of Director, Quality
Assurance. Provide leadership for quality systems. Major task
during GMP projects is to provide guidance and leadership in
regards to quality and customer relations with GMP Operations and
GMP Analytical. Responsibilities:
- Supervision of Quality Assurance staff: This function includes
Performance Management activities such as promotion and performance
ratings recommendation, performance appraisals writing; time/shift
scheduling; overtime approval recommendation; and participation in
- Serve as main representative for Quality Assurance.
- Provide guidance in the development of SOPs; approve, maintain,
and distribute SOPs; train and update personnel on new SOPs.
- Review and approve batch records and supporting documents.
- Perform final project release for GMP projects.
- Review and approve shipping process for GMP materials.
- Generate Quality Certificates.
- Manage efforts of staff.
- Train and develop staff.
- Review and approve change control and qualification for
equipment and facility.
- Develop and review quality metric systems.
- Manage the data review system for GMP analytical testing.
- Oversee CAPA program. Infrequent Functions:
- Support management of nonGMP facility
- Consult with company vendors
- Perform duties as listed for all Quality Assurance staff as
- BS, MS or Ph.D. in Chemistry (or closely related
- A minimum of at least 10 years of relevant
background/leadership in GXP/QA/regulatory compliant pharmaceutical
- Knowledge of GMP manufacturing and analytical techniques to
support QA process.
- Expertise in creating and interpreting SOPs. Ability to
function as technical expert/consultant. Other Desirable experience
- Excellent verbal and written communication and interpersonal
skills, problem-solving, and organizational skills.
- Track record of successfully applying high level scientific
judgment in a variety of complex and unprecedented situations.
- Proven ability to act independently to achieve pre-determined
goals and objectives and obtain desired results.
- Ability to coach and develop staff and to transfer job
knowledge and skills. Cambrex is an Equal Opportunity / Affirmative
Action employer and will consider all qualified applicants for
employment without regard to race, color, religion, gender, sexual
orientation, gender identity, national origin, age, protected
veteran status, or disability status. Be the first to receive our
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Keywords: Cambrex Corporation, High Point , Director, Quality Assurance, Executive , High Point, North Carolina
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