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Manager, QA Compliance

S

Simply Biotech

Manager, QA Compliance

San Diego, CA
Full Time
Paid
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  • Responsibilities

    Job Description

    MANAGER, QA COMPLIANCE - SIMPLY BIOTECH

    OVERVIEW

    Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

    Immediate opening for a Manager, QA Compliance in San Diego, CA who possesses:

    • BS in a life sciences or engineering discipline
    • 7+ years of QA experience in a regulated industry (biotech or pharma are preferred) + 3+ years of management/supervisory experience
    • Experienced with aseptic processing (RABS and Isolator experience preferred) and regulatory principles
    • Working knowledge of GMP, FDA, ICH guidelines
    • Experienced with QMS (Master Control, ETQ, ACE, Track Wise, etc.)

    Email resumes to ajones@simplybiotech.com or call 858.251.3562

    FULL DESCRIPTION: OUR CLIENT IS CURRENTLY SEEKING A MANAGER OF QA COMPLIANCE TO JOIN THE TEAM AND LEAD AUDIT INSPECTION READINESS FOR THE COMPANY'S CLINICAL AND COMMERCIAL MANUFACTURING FACILITIES. THIS ROLE OVERSEES QUALITY MANAGEMENT SYSTEM (QMS) ACTIVITIES SUCH AS RISK ASSESSMENTS, AUDIT FOLLOW-UPS, AND CLIENT CONTRACTUAL AGREEMENTS TO ENSURE COMPLIANCE WITH U.S. AND INTERNATIONAL REGULATORY REQUIREMENTS.

    The selected candidate will further possess:

    • Minimum of 3 years of leadership or supervisory experience.
    • Experience with aseptic processing; experience with restricted access barrier systems (RABS) and isolators preferred.
    • Working knowledge of cGMPs, FDA regulations, ICH Guidelines in drug/device, and familiarity with the European Community guidelines for cGMPs.
    • Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
    • Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
    • Experience with process mapping, data analysis and presentation software such as Visio, Microsoft office, Excel, PowerPoint, etc.

     

    The selected candidate will be responsible for the following:

    • Manages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs.
    • Develops technical acumen and decision-making skills in direct reports.
    • Oversees Company's risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders.
    • Leads complex audit, deviation and CAPA investigations.
    • In collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality.
    • Manages quality event trend reports and metrics to measure key quality attributes.
    • Accountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations.
    • Develops and maintains relevant quality sections of contractual agreements with clients.
    • Directs and provides expert knowledge in the day-to-day function of QA Compliance.
    • Identifies, recruits, and retains top-notch talent.
    • Champions Company's culture and empowers employees to take responsibility for their jobs and goals.
    • Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
    • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
    • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
    • Embodies Company cultural values and aligns daily actions with department goals and company culture.

    For immediate and confidential consideration, please email your resume to ajones@simplybiotech.com or call 858.251.3562

    More information can be found at www.simplybiotech.com

    Company Description

    IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater Los Angeles area - opportunities you won’t find on your own. THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right. THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.