Apex Systems Looking for Sr. Manager of Quality Control at Cambridge, MA Full Time

Job Scope & Purpose:

This key Quality Control leader will oversee a small growing team within an exciting innovator in the highly exciting Gene Therapy space. Our Cambridge based client is looking for a hands-on leader to oversee the stability, method qualification and validation programs. You will also lead the Method Validation team to collaborate on internal and external method development, validation, optimization and method life cycle initiatives.

Primary Job Responsibilities:

• Track and document all Quality Control activities such as stability, reference standard inventory, method validation status
• Facilitate review, revision, and approval activities of QC documents ensuring both internal and external systems comply with regulatory requirements
• Manage all OOS investigations and drive to closure
• Trend and report QC related metrics (testing turn-around times, investigations, stability, reference standard inventory) both internally and from external vendors
• Interface with business partners and external vendors in ensuring quality control activities are prioritized and completed on time and with a high degree of quality
• Contribute to the development of new QC systems and standards
• Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management System.

Primary Job Requirements:

• BS or MS with 5+ years of GMP Biologic Quality Control experience
• Knowledge skilled in various analytical testing methods including UPLC, UV/vis, CE, GS, Bioassay, PCR, Gel Electrophoresis, MS, Potency, Biological Assays and microbiology assays.
• Experience managing internal and external resources including testing labs
• Demonstrated proficiency with Quality System Records, OOS, Deviations, Change Controls and CAPAs
• Skilled in technical writing for method validation documentation, QC trending reports, technical assessments for investigations and change controls and CMC sections of regulatory filings.
• Knowledge of FDA/EMA/ICH regulations and experience with GMP guidelines
• Able to manage multiple priorities with aggressive timelines
• Self-starter with strong verbal and written communication skills

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code: TechOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .