Manager, Quality Assurance
Company: Disability Solutions
Location: Raleigh
Posted on: April 22, 2024
Job Description:
** This role is onsite in Raleigh office 3 days a week and 2
remote **Who We Are: Harvesting Hope with a Growing FamilyAt Merz
Therapeutics, we take a nurturing approach to our organization -
treating colleagues like family, embracing our whole selves and
creating a company culture that encourages growth and decisive
action. We are committed to caring for whole communities by
focusing on individuals suffering from movement disorders and
neurological conditions and the healthcare providers dedicated to
helping them, while simultaneously bolstering our team members in a
united effort to make a difference.As a private, family-owned
company, we have the liberty and support to make decisions for
ourselves, our customers and the patients we serve. We pride
ourselves on building an inclusive culture where there is room to
celebrate individual growth and the ability to contribute to a
common good as a collaborative team. Our mission is grounded in a
long-term view of making a difference for the common good, while
growing together as a family.If you're looking to immerse yourself
in a passionate team rooted in community, connection and
camaraderie, then we're looking for YOU! #IAmMerzTxMerz
Therapeutics is seeking a Manager, Quality Assurance. This role
will be the local Quality Management System representative and be
responsible for development and oversight of Supplier Management
Program. The role will be the Liaison to global Quality functions
and will focus on compliance of operations with quality related
requirements set by authorities and Merz-internal.Essential Duties
and ResponsibilitiesLocal Quality Assurance
- Contributing to the development and operations of the Quality
Management System requirements for Merz Therapeutics U.S. within
Global therapeutics Quality Management System
- Responsible for contributing to local Quality Management
Reviews and writing the Annual Quality Management Report
- Working with regulatory officials during local quality
inspections and supporting all Merz sites globally with any
requests for information from an authority inspection
- Local lead for Merz Therapeutics U.S. and Canadian recall
activities (process, communication, reporting)
- Managing contracts and budget with local quality vendors
- Lead local contact for internal corporate audits and authority
inspections
- Overseeing Supplier Management program through supplier
qualification activities, supplier audits, maintaining contracts,
monitoring performance and maintaining the audit schedule
- Monitoring, tracking and investigating deviations
- Corrective and Preventive Action (CAPA) activity
implementation, reporting, and close out
- Building a company culture of quality through training, quality
initiatives
- Driving quality improvement activities
- Creating, revising, maintaining Quality Assurance
Agreements
- Creating work processes for local QA and writing corresponding
SOPs.
- Provides local QA oversight for GXP systems and applies
risk-based methodology to validation/qualification efforts
- Provide quality assurance oversight for production, testing and
release of packaging activities at 3PL vendor(s)
- Provide quality assurance oversight for distribution of
products in North AmericaGlobal Quality Assurance Collaboration
- Responsible for maintaining compliance with Global Therapeutics
Quality Management System
- Participating in internal auditing system by global quality
assurance
- Liaison to Global Quality functions, ensuring local compliance
to global requirements and ensuring consideration for local
requirements within global system
- Participate in cross-functional project teams, when
appropriate
- Managing collaborative relationship with Global therapeutics
R&D, Global Technical Operations and Global Aesthetics Quality
Management teamOther duties as assigned
- Supporting local leadership in any safety/quality objectives as
applicable
- Staying up-to-date on all SOP reading/training
requirements
- Notify manager of regulatory compliance questions and
issues
- Backup to team members as needed including technical complaint
management, Document control activities, training, etc.Job related
qualifications/SkillsEducationBachelor's degree (Health Sciences,
Science, Biology, Chemistry, Nursing, Pharmacy or related field)
Required Professional experience
- Minimum of 8+ years of experience in the pharmaceutical or
biotechnology industry with at least 5 of those years in QA or
closely related field Required
- Experience conducting internal and/or supplier audits as a lead
auditor Required
- Experience performing formal drug product release for market
distribution Preferred
- Experience working in and with different people and
organizational cultures, supporting people with diverse
backgrounds, attitudes and cultural differences Preferred
- Experience hosting or contributing to authority GMP inspections
Required
- Certification as a Quality Auditor RequiredKnowledge, skills
and abilities (incl. languages)
- Thorough understanding of quality assurance and ability to
communicate with Regulatory and Quality personnel Required
- Must be proficient in Microsoft Office applications including
Word, Excel and PowerPoint PreferredKnowledge of methods
- Working knowledge of GMP, US Food and Drug Regulations,
including biologics RequiredPersonal skills
- Strong interpersonal and team collaboration skills
Required
- Excellent verbal and written communication skills. Ability to
clearly articulate quality concepts Preferred
- Strong multi-tasking, time management, and organizational
skills PreferredDon't meet every single requirement? Studies have
shown that women and people of color are less likely to apply to
jobs unless they meet every single qualification. At Merz
Therapeutics we are dedicated to building a diverse, inclusive, and
authentic workplace, so if you're excited about this role but your
past experience doesn't align perfectly with every qualification in
the job description, we encourage you to apply anyways. You may be
just the right candidate for this or other roles.Recruitment Note:
Merz Therapeutics only sends emails from verified "merz.com"
addresses and never asks for sensitive, personal information or
money. If you have any doubts about the authenticity of any type of
communication from, or on behalf of Merz Therapeutics, please
contact Therapeutics.HR@merz.com
Keywords: Disability Solutions, Raleigh , Manager, Quality Assurance, Accounting, Auditing , Raleigh, North Carolina
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