Supervisor, Quality Systems - GMP

Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness
Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary:

The Supervisor, Quality Management Systems supervises and coordinates the activities of an assigned team and provides technical leadership in areas of Quality Systems, Documentation Systems, and administration of the eQMS. Staff may include hourly non-exempt and/or salaried exempt employees. The Supervisor is expected to coach, train, and develop the skills of the subordinate staff. This role will interact with external clients/vendors and is responsible for successfully meeting client/vendor and departmental objectives in a timely manner.

On-Site Expectations:

• 100% on-site position.

Responsibilities:

• Represents the department in meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
• Manages the day-to-day operations for assigned area.
• Ensures all staff members are fully trained.
• Actively participates and contributes to the preparation and support of client and internal audits as well as regulatory inspections.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
• Effectively resolves related technical/business related and/or quality issues and concerns in a timely manner.
• Creates strong and effective relationships with internal and external clients.
• Maintains a high level of professional and technical/business expertise through participation in training courses.
• Other duties as assigned.

Qualifications:

• Bachelor's degree required.
• 4+ years applicable experience.
• 1 to 2+ years in leadership roles.
• Applicable experience in operational areas may require experience to be a CDMO or regulated area.

Knowledge, Skills, and Abilities:

• Basic business acumen.
• Effective listening skills with the ability to listen attentively and process and relay information correctly.
• Good verbal and written communication and documentation skills required.
• Highly effective team and interpersonal skills with the ability to work across numerous management disciplines.
• Good analytical and problem-solving skills, with the ability to think strategically.
• High level personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Highly goal and result oriented.
• Treats colleagues at all levels with respect.
• Good detail orientation and organizational skills required.
• Able to troubleshoot and solve basic and moderately complex problems.
• Strong technical skills for area managing.
• Good knowledge of cGMP in a pharmaceutical or regulated environment.
• Good knowledge of FDA, EU and ICH requirements and implementation in the pharmaceutical industry based on area being managed.
• Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites, for cGMP areas.
• Understands how to prioritize tasks according to business objectives and can pursue several objectives simultaneously.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
• Proficiency and experience with eQMS platforms, MasterControl preferred.

Travel Expectations:

• Up to 15% travel may be required.

Physical Demands and Work Environment:

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, half face and full face respirator, lab coats, full protective body coverings, various types of gloves, etc.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami 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.